Post-acute COVID-19 Syndrome
Conditions
Brief summary
The multicenter, double-blind, placebo-controlled, parallel-group, randomized clinical trial. The objective of this study is to evaluate the efficacy and safety of Prospekta in the treatment of asthenia in patients after the coronavirus infectious disease (COVID-19).
Detailed description
Design: the multicenter, double-blind, placebo-controlled, parallel-group, randomized clinical trial. The study will enroll adult patients of either gender aged 18 to 65 years after new coronavirus infection of 2019 (COVID-19) with symptoms of asthenia that appeared during or after an acute coronavirus infection (COVID-19) and persisting 4 to 12 weeks from the onset of coronavirus infection. After the patient signs the patient information sheet and the informed consent form for participation in the study, complaints, medical history, physical examination, registration of vital signs are collected, the patient fills in the Fatigue Severity Scale (FSS) and Hospital Anxiety and Depression Scale (HADS). A six-minute walk test (6MWT) is carried out. The physician evaluates the severity of asthenia with FSS scale and records concomitant medications, co-morbidities and concurrent conditions. If a patient meets all inclusion criteria and does not have any of the exclusion criteria at Visit 1 (Day 1), he/she is randomized to one of two groups: Group 1 - patients receive Prospekta at a dose of 1 tablet twice daily for 4 weeks; Group 2 - patients receive placebo on the study drug regimen. The trial will use electronic patient diaries (EPD). The patient should record any possible deterioration (if applicable) in the EPD. At Visit 1 (Day 1), the physician will provide guidance on how to work with EPD, so that the patient can use it independently in the future. At Visit 2 (Week 4 ± 3 days), the physician will collect patient's complaints, record physical examination data and vital signs as well as any changes in concurrent diseases and conditions. The patient fills out the FSS and HADS scales. A 6MWT is carried out. The physician monitors the prescribed treatment and use of concomitant medications, evaluates the safety of the study treatment and patient's compliance, filling out the diary. The patient stops taking the study drug. At the end of the study treatment period, the patient is monitored for 4 weeks (follow-up period). At Visit 3 (final visit, Week 8 ± 3 days), the physician collects patient's complaints, records physical examination data and vital signs, changes in concomitant diseases and conditions. The patient fills in the FSS and HADS scales. A 6MWT is carried out. The physician evaluates the safety of the study treatment, checks the completion of the diary. During the study the patients are allowed to take medications for their chronic conditions, except for medicines listed as Prohibited concomitant treatment.
Interventions
DRUGProspekta
Oral administration.
DRUGPlacebo
Oral administration.
Sponsors
Materia Medica Holding
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
double-blind, placebo-controlled, parallel-group, randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Adults of either gender aged 18 to 65 years inclusive. 2. Patients within 4-12 weeks of the confirmed COVID-19 onset . 3. Symptoms of asthenia that appeared during or after an acute new coronavirus infection (COVID-19), persisting from 4 to 12 weeks from the onset of coronavirus infection. 4. Presence of asthenia (≥36 on the FSS scale). 5. Patients who agreed to use a reliable method of contraception during the study (for men and women with reproductive potential). 6. Presence of a signed information sheet and informed consent form for participation in a clinical trial.
Exclusion criteria
1. History / suspicion of cancer of any localization (with the exception of benign neoplasms). 2. More than 75% of lung tissue damage during the period of COVID-19 disease (CT 4). 3. Cerebrovascular diseases with the development of moderate to severe cognitive impairments. 4. Uncontrolled arterial hypertension characterized by the following blood tension values: systolic blood pressure \> 180 mm Hg and/or diastolic blood pressure \> 110 mm Hg. 5. Myocardial infarction, stroke in the previous 6 months. 6. Nervous system disorders with persistent neurological impairment. 7. Autoimmune diseases. 8. Decompensated diseases of the cardiovascular system, liver, kidney, gastrointestinal tract, and metabolic, respiratory, endocrine or hematological diseases, peripheral vascular disorders. 9. Any severe comorbidity which, in the opinion of the investigator, may affect patient participation in the clinical trial. 10. Hypersensitivity to any of the components of the study drug. 11. Hereditary lactose intolerance, lactose malabsorption, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia. 12. Pregnancy, breast-feeding; childbirth less than 3 months prior to the inclusion in the trial, unwillingness to use contraceptive methods during the trial (for men and women with reproductive potential). 13. Patients, who, from the investigator's point of view, will not comply with study observation requirements or study drug administration procedures.. 14. Prior history of mental illness, alcoholism or drug abuse, that the investigator's opinion, will interfere with successful study procedures. 15. Use of any medications listed in Prohibited concomitant treatment within 1 week before enrollment. 16. Participation in other clinical studies within 3 months prior to enrollment in the study. 17. Patients who are related to any of the on-site research personnel directly involved in the conduct of the trial or are an immediate relative of the study investigator. Immediate relative means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted). 18. Participants who work for OOO NPF MATERIA MEDICA HOLDING (i.e. the company's employees, temporary contract workers, designated officials responsible for carrying out the research or any immediate relatives of the aforementioned).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Mean FSS Score. | after 4 weeks of treatment | Fatigue Severity Scale (FSS). Change in the mean FSS score after 4 weeks of treatment. The total score of the scale, which consists of 9 questions, varies between 9-63. This scale consists of a 7-point Likert scale. 1 point means strongly disagree, 7 means strongly agree. People are asked to mark the appropriate options for each question taking into account their status in the last 1 month period. A total of 36 points and above indicate fatigue. A higher score is indicated high level of fatigue. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Severity of Anxiety on the HADS Subscale. | after 4 weeks of treatment | Hospital Anxiety and Depression Scale (HADS). Change in the severity of anxiety and depression on the HADS subscales after 4 weeks of treatment. The scale is composed of 14 statements serving 2 subscales: anxiety (odd items - 1, 3, 5, 7, 9, 11, 13) and depression (even items - 2, 4, 6, 8, 10, 12 , 14). Each statement corresponds to 4 answer options, reflecting the gradation of the severity of the sign and coded according to the increase in the severity of the symptom from 0 (no) to 3 (maximum severity). When interpreting the results, the total indicator for each subscale is taken into account, while there are 3 areas of its values: 0-7 - norm (absence of reliably expressed symptoms of anxiety and depression); 8-10 - subclinical anxiety / depression; 11 and above - clinical anxiety / depression. The anxiety subscale ranges from 0 to 21, with higher values reflecting a worse outcome. |
| Change in the Severity of Depression on the HADS Subscale. | after 4 weeks of treatment | Hospital Anxiety and Depression Scale (HADS). Change in the severity of depression on the HADS subscale after 4 weeks of treatment. The scale is composed of 14 statements serving 2 subscales: anxiety (odd items - 1, 3, 5, 7, 9, 11, 13) and depression (even items - 2, 4, 6, 8, 10, 12 , 14). Each statement corresponds to 4 answer options, reflecting the gradation of the severity of the sign and coded according to the increase in the severity of the symptom from 0 (no) to 3 (maximum severity). When interpreting the results, the total indicator for each subscale is taken into account, while there are 3 areas of its values: 0-7 - norm (absence of reliably expressed symptoms of anxiety and depression); 8-10 - subclinical anxiety / depression; 11 and above - clinical anxiety / depression. The depression subscale ranges from 0 to 21, with higher values reflecting a worse outcome. |
| Change in the Mean FSS Score Within Follow-up Period. | after 4 weeks of treatment and after 4 weeks of follow-up at week 8 | Change in mean FSS score over 4 weeks of follow-up period at the end of treatment. The total score of the scale, which consists of 9 questions, varies between 9-63. This scale consists of a 7-point Likert scale. 1 point means strongly disagree, 7 means strongly agree. People are asked to mark the appropriate options for each question taking into account their status in the last 1 month period. A total of 36 points and above indicate fatigue. A higher score is indicated high level of fatigue. |
| Change in Distance of the 6-minute Walk Test Within Follow-up Period. | after 4 weeks of treatment and after 4 weeks of follow-up at week 8 | Change in distance when performing the 6-minute walk test over a 4-week follow-up period at the end of treatment. The test is carried out with the aim of objectively assessing the patient's physical tolerance. The patient should walk the maximum possible distance for himself at his own pace on a flat surface in 6 minutes. |
| Change in the Severity of Anxiety on the HADS Subscales Within Follow-up Period. | after 4 weeks of treatment and after 4 weeks of follow-up at week 8 | Change in the severity of anxiety on the HADS subscales over a 4-week follow-up period at the end of treatment. The scale is composed of 14 statements serving 2 subscales: anxiety (odd items - 1, 3, 5, 7, 9, 11, 13) and depression (even items - 2, 4, 6, 8, 10, 12 , 14). Each statement corresponds to 4 answer options, reflecting the gradation of the severity of the sign and coded according to the increase in the severity of the symptom from 0 (no) to 3 (maximum severity). When interpreting the results, the total indicator for each subscale is taken into account, while there are 3 areas of its values: 0-7 - norm (absence of reliably expressed symptoms of anxiety and depression); 8-10 - subclinical anxiety / depression; 11 and above - clinical anxiety / depression. The anxiety subscale ranges from 0 to 21, with higher values reflecting a worse outcome. |
| Change in the Severity of Depression on the HADS Subscales Within Follow-up Period. | after 4 weeks of treatment and after 4 weeks of follow-up at week 8 | Change in the severity of depression on the HADS subscales over a 4-week follow-up period at the end of treatment. The scale is composed of 14 statements serving 2 subscales: anxiety (odd items - 1, 3, 5, 7, 9, 11, 13) and depression (even items - 2, 4, 6, 8, 10, 12 , 14). Each statement corresponds to 4 answer options, reflecting the gradation of the severity of the sign and coded according to the increase in the severity of the symptom from 0 (no) to 3 (maximum severity). When interpreting the results, the total indicator for each subscale is taken into account, while there are 3 areas of its values: 0-7 - norm (absence of reliably expressed symptoms of anxiety and depression); 8-10 - subclinical anxiety / depression; 11 and above - clinical anxiety / depression. The depression subscale ranges from 0 to 21, with higher values reflecting a worse outcome. |
| Change in Distance of the 6-minute Walk Test. | after 4 weeks of treatment | Change in distance when performing the 6-minute walk test after 4 weeks of treatment. The test is carried out with the aim of objectively assessing the patient's physical tolerance. The patient should walk the maximum possible distance for himself at his own pace on a flat surface in 6 minutes. |
| Changes in Vital Signs (Respiration Rate (Breathing Rate)). | after 4 weeks of treatment and within 4 weeks of the follow-up period at the end of the treatment (Visit 1: baseline, Visit 2: after 4 weeks of treatment, and Visit 3: after 4 weeks of follow-up at week 8) | Based on medical records. Vital signs will be measured in a medical setting. |
| Changes in Vital Signs (Blood Pressure). | after 4 weeks of treatment and within 4 weeks of the follow-up period at the end of the treatment (Visit 1: baseline, Visit 2: after 4 weeks of treatment, and Visit 3: after 4 weeks of follow-up at week 8). | Based on medical records. Vital signs will be measured in a medical setting. |
| Presence of Adverse Events (AEs). | 8 weeks | The number of participants with adverse events (AEs). Based on medical records. |
| The Severity of AEs. | 8 weeks | The intensity (severity) of adverse events. Based on medical records. |
| The Outcome of AEs. | 8 weeks | The outcome of adverse events. Based on medical records. |
| AEs Causal Relationship to the Study Drug. | 8 weeks | The adverse events causal relationship to the study drug. Based on medical records. |
| Changes in Vital Signs (Pulse Rate (Heart Rate)). | after 4 weeks of treatment and within 4 weeks of the follow-up period at the end of the treatment. | Based on medical records. Vital signs will be measured in a medical setting. |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prospekta Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15 minutes before eating or drinking), keep the tablets in the mouth, without swallowing, until completely dissolved.
Prospekta: Oral administration. | 330 |
| Placebo Tablet for oral use. Placebo using Prospekta scheme.
Placebo: Oral administration. | 346 |
| Total | 676 |
Baseline characteristics
| Characteristic | Placebo | Total | Prospekta |
|---|---|---|---|
| Age, Continuous | 42.8 years STANDARD_DEVIATION 12.6 | 43.5 years STANDARD_DEVIATION 12.6 | 44.3 years STANDARD_DEVIATION 12.5 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Russia | 346 participants | 676 participants | 330 participants |
| Sex: Female, Male Female | 236 Participants | 452 Participants | 216 Participants |
| Sex: Female, Male Male | 110 Participants | 224 Participants | 114 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 330 | 0 / 346 |
| other Total, other adverse events | 20 / 330 | 20 / 346 |
| serious Total, serious adverse events | 0 / 330 | 0 / 346 |
Outcome results
Primary
Change in the Mean FSS Score.
Fatigue Severity Scale (FSS). Change in the mean FSS score after 4 weeks of treatment. The total score of the scale, which consists of 9 questions, varies between 9-63. This scale consists of a 7-point Likert scale. 1 point means strongly disagree, 7 means strongly agree. People are asked to mark the appropriate options for each question taking into account their status in the last 1 month period. A total of 36 points and above indicate fatigue. A higher score is indicated high level of fatigue.
Time frame: after 4 weeks of treatment
Population: Six patients were excluded from the trial before 4 week therefore no data was collected on 4 weeks timepoint (3 patients from Prospekta group and 3 patients from Placebo group).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prospekta | Change in the Mean FSS Score. | Baseline | 46.4 score on a scale | Standard Deviation 6.9 |
| Prospekta | Change in the Mean FSS Score. | After 4 weeks | 29.9 score on a scale | Standard Deviation 9.2 |
| Prospekta | Change in the Mean FSS Score. | ∆ between baseline and 4 weeks later | 16.5 score on a scale | Standard Deviation 9.5 |
| Placebo | Change in the Mean FSS Score. | Baseline | 45.9 score on a scale | Standard Deviation 6.6 |
| Placebo | Change in the Mean FSS Score. | After 4 weeks | 31.9 score on a scale | Standard Deviation 9.9 |
| Placebo | Change in the Mean FSS Score. | ∆ between baseline and 4 weeks later | 14.0 score on a scale | Standard Deviation 9.4 |
Comparison: This analysis applies to ∆ between baseline and 4 weeks later row.p-value: 0.0016Wilcoxon (Mann-Whitney)
Secondary
AEs Causal Relationship to the Study Drug.
The adverse events causal relationship to the study drug. Based on medical records.
Time frame: 8 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prospekta | AEs Causal Relationship to the Study Drug. | No relation | 20 number of AEs |
| Prospekta | AEs Causal Relationship to the Study Drug. | Probable | 3 number of AEs |
| Prospekta | AEs Causal Relationship to the Study Drug. | Possible | 1 number of AEs |
| Prospekta | AEs Causal Relationship to the Study Drug. | Doubtful | 0 number of AEs |
| Placebo | AEs Causal Relationship to the Study Drug. | Doubtful | 9 number of AEs |
| Placebo | AEs Causal Relationship to the Study Drug. | No relation | 15 number of AEs |
| Placebo | AEs Causal Relationship to the Study Drug. | Possible | 0 number of AEs |
| Placebo | AEs Causal Relationship to the Study Drug. | Probable | 4 number of AEs |
p-value: 0.004Fisher Exact
Secondary
Change in Distance of the 6-minute Walk Test.
Change in distance when performing the 6-minute walk test after 4 weeks of treatment. The test is carried out with the aim of objectively assessing the patient's physical tolerance. The patient should walk the maximum possible distance for himself at his own pace on a flat surface in 6 minutes.
Time frame: after 4 weeks of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prospekta | Change in Distance of the 6-minute Walk Test. | Baseline | 426.4 meters | Standard Deviation 119.2 |
| Prospekta | Change in Distance of the 6-minute Walk Test. | After 4 weeks | 457.8 meters | Standard Deviation 118.2 |
| Prospekta | Change in Distance of the 6-minute Walk Test. | ∆ between baseline and 4 weeks later | 31.4 meters | Standard Deviation 44.5 |
| Placebo | Change in Distance of the 6-minute Walk Test. | Baseline | 416.9 meters | Standard Deviation 112.8 |
| Placebo | Change in Distance of the 6-minute Walk Test. | After 4 weeks | 444.7 meters | Standard Deviation 110.7 |
| Placebo | Change in Distance of the 6-minute Walk Test. | ∆ between baseline and 4 weeks later | 27.8 meters | Standard Deviation 38.1 |
Comparison: This analysis applies to ∆ between baseline and 4 weeks later row.p-value: 0.3183Wilcoxon (Mann-Whitney)
Secondary
Change in Distance of the 6-minute Walk Test Within Follow-up Period.
Change in distance when performing the 6-minute walk test over a 4-week follow-up period at the end of treatment. The test is carried out with the aim of objectively assessing the patient's physical tolerance. The patient should walk the maximum possible distance for himself at his own pace on a flat surface in 6 minutes.
Time frame: after 4 weeks of treatment and after 4 weeks of follow-up at week 8
Population: One patient in Prospekta group and three patients in Placebo group were excluded from the trial before finishing follow-up period therefore no data was collected within 4 weeks of follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prospekta | Change in Distance of the 6-minute Walk Test Within Follow-up Period. | After 4 weeks | 457.8 meter | Standard Deviation 118.2 |
| Prospekta | Change in Distance of the 6-minute Walk Test Within Follow-up Period. | After 8 weeks | 472.9 meter | Standard Deviation 116.5 |
| Prospekta | Change in Distance of the 6-minute Walk Test Within Follow-up Period. | ∆ between value after 4 weeks and after 8 weeks | 15.9 meter | Standard Deviation 32.1 |
| Placebo | Change in Distance of the 6-minute Walk Test Within Follow-up Period. | After 4 weeks | 444.7 meter | Standard Deviation 110.7 |
| Placebo | Change in Distance of the 6-minute Walk Test Within Follow-up Period. | After 8 weeks | 462.7 meter | Standard Deviation 110.1 |
| Placebo | Change in Distance of the 6-minute Walk Test Within Follow-up Period. | ∆ between value after 4 weeks and after 8 weeks | 18.8 meter | Standard Deviation 32 |
Comparison: This analysis applies to ∆ between value after 4 weeks and after 8 weeks row.p-value: 0.1049Wilcoxon (Mann-Whitney)
Secondary
Change in the Mean FSS Score Within Follow-up Period.
Change in mean FSS score over 4 weeks of follow-up period at the end of treatment. The total score of the scale, which consists of 9 questions, varies between 9-63. This scale consists of a 7-point Likert scale. 1 point means strongly disagree, 7 means strongly agree. People are asked to mark the appropriate options for each question taking into account their status in the last 1 month period. A total of 36 points and above indicate fatigue. A higher score is indicated high level of fatigue.
Time frame: after 4 weeks of treatment and after 4 weeks of follow-up at week 8
Population: One patient in Prospekta group was excluded from the trial before finishing follow-up period therefore no data was collected within 4 weeks of follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prospekta | Change in the Mean FSS Score Within Follow-up Period. | After 4 weeks | 29.9 score on a scale | Standard Deviation 9.2 |
| Prospekta | Change in the Mean FSS Score Within Follow-up Period. | After 8 weeks | 22.9 score on a scale | Standard Deviation 9 |
| Prospekta | Change in the Mean FSS Score Within Follow-up Period. | ∆ between value after 4 weeks and after 8 weeks | 7.1 score on a scale | Standard Deviation 6.3 |
| Placebo | Change in the Mean FSS Score Within Follow-up Period. | After 4 weeks | 31.9 score on a scale | Standard Deviation 9.9 |
| Placebo | Change in the Mean FSS Score Within Follow-up Period. | After 8 weeks | 25.0 score on a scale | Standard Deviation 10.2 |
| Placebo | Change in the Mean FSS Score Within Follow-up Period. | ∆ between value after 4 weeks and after 8 weeks | 7.0 score on a scale | Standard Deviation 6.9 |
Comparison: This analysis applies to ∆ between value after 4 weeks and after 8 weeks row.p-value: 0.8156Wilcoxon (Mann-Whitney)
Secondary
Change in the Severity of Anxiety on the HADS Subscale.
Hospital Anxiety and Depression Scale (HADS). Change in the severity of anxiety and depression on the HADS subscales after 4 weeks of treatment. The scale is composed of 14 statements serving 2 subscales: anxiety (odd items - 1, 3, 5, 7, 9, 11, 13) and depression (even items - 2, 4, 6, 8, 10, 12 , 14). Each statement corresponds to 4 answer options, reflecting the gradation of the severity of the sign and coded according to the increase in the severity of the symptom from 0 (no) to 3 (maximum severity). When interpreting the results, the total indicator for each subscale is taken into account, while there are 3 areas of its values: 0-7 - norm (absence of reliably expressed symptoms of anxiety and depression); 8-10 - subclinical anxiety / depression; 11 and above - clinical anxiety / depression. The anxiety subscale ranges from 0 to 21, with higher values reflecting a worse outcome.
Time frame: after 4 weeks of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prospekta | Change in the Severity of Anxiety on the HADS Subscale. | Baseline | 8.5 score on a scale | Standard Deviation 4.1 |
| Prospekta | Change in the Severity of Anxiety on the HADS Subscale. | After 4 weeks | 5.5 score on a scale | Standard Deviation 3.2 |
| Prospekta | Change in the Severity of Anxiety on the HADS Subscale. | ∆ between baseline and 4 weeks later | 3.0 score on a scale | Standard Deviation 3.2 |
| Placebo | Change in the Severity of Anxiety on the HADS Subscale. | Baseline | 8.8 score on a scale | Standard Deviation 3.9 |
| Placebo | Change in the Severity of Anxiety on the HADS Subscale. | After 4 weeks | 6.0 score on a scale | Standard Deviation 3.3 |
| Placebo | Change in the Severity of Anxiety on the HADS Subscale. | ∆ between baseline and 4 weeks later | 2.8 score on a scale | Standard Deviation 3.1 |
Comparison: This analysis applies to ∆ between baseline and 4 weeks later row.p-value: 0.5805Wilcoxon (Mann-Whitney)
Secondary
Change in the Severity of Anxiety on the HADS Subscales Within Follow-up Period.
Change in the severity of anxiety on the HADS subscales over a 4-week follow-up period at the end of treatment. The scale is composed of 14 statements serving 2 subscales: anxiety (odd items - 1, 3, 5, 7, 9, 11, 13) and depression (even items - 2, 4, 6, 8, 10, 12 , 14). Each statement corresponds to 4 answer options, reflecting the gradation of the severity of the sign and coded according to the increase in the severity of the symptom from 0 (no) to 3 (maximum severity). When interpreting the results, the total indicator for each subscale is taken into account, while there are 3 areas of its values: 0-7 - norm (absence of reliably expressed symptoms of anxiety and depression); 8-10 - subclinical anxiety / depression; 11 and above - clinical anxiety / depression. The anxiety subscale ranges from 0 to 21, with higher values reflecting a worse outcome.
Time frame: after 4 weeks of treatment and after 4 weeks of follow-up at week 8
Population: One patient in Prospekta group and three patients in Placebo group were excluded from the trial before finishing follow-up period therefore no data was collected within 4 weeks of follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prospekta | Change in the Severity of Anxiety on the HADS Subscales Within Follow-up Period. | After 4 weeks | 5.5 score on a scale | Standard Deviation 3.2 |
| Prospekta | Change in the Severity of Anxiety on the HADS Subscales Within Follow-up Period. | After 8 weeks | 4.0 score on a scale | Standard Deviation 2.8 |
| Prospekta | Change in the Severity of Anxiety on the HADS Subscales Within Follow-up Period. | ∆ between value after 4 weeks and after 8 weeks | 1.5 score on a scale | Standard Deviation 2.3 |
| Placebo | Change in the Severity of Anxiety on the HADS Subscales Within Follow-up Period. | After 4 weeks | 6.0 score on a scale | Standard Deviation 3.3 |
| Placebo | Change in the Severity of Anxiety on the HADS Subscales Within Follow-up Period. | After 8 weeks | 4.4 score on a scale | Standard Deviation 3 |
| Placebo | Change in the Severity of Anxiety on the HADS Subscales Within Follow-up Period. | ∆ between value after 4 weeks and after 8 weeks | 1.6 score on a scale | Standard Deviation 2.3 |
Comparison: This analysis applies to ∆ between value after 4 weeks and after 8 weeks row.p-value: 0.726Wilcoxon (Mann-Whitney)
Secondary
Change in the Severity of Depression on the HADS Subscale.
Hospital Anxiety and Depression Scale (HADS). Change in the severity of depression on the HADS subscale after 4 weeks of treatment. The scale is composed of 14 statements serving 2 subscales: anxiety (odd items - 1, 3, 5, 7, 9, 11, 13) and depression (even items - 2, 4, 6, 8, 10, 12 , 14). Each statement corresponds to 4 answer options, reflecting the gradation of the severity of the sign and coded according to the increase in the severity of the symptom from 0 (no) to 3 (maximum severity). When interpreting the results, the total indicator for each subscale is taken into account, while there are 3 areas of its values: 0-7 - norm (absence of reliably expressed symptoms of anxiety and depression); 8-10 - subclinical anxiety / depression; 11 and above - clinical anxiety / depression. The depression subscale ranges from 0 to 21, with higher values reflecting a worse outcome.
Time frame: after 4 weeks of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prospekta | Change in the Severity of Depression on the HADS Subscale. | After 4 weeks | 4.7 score on a scale | Standard Deviation 2.9 |
| Prospekta | Change in the Severity of Depression on the HADS Subscale. | Baseline | 8.1 score on a scale | Standard Deviation 3.7 |
| Prospekta | Change in the Severity of Depression on the HADS Subscale. | ∆ between baseline and 4 weeks later | 3.4 score on a scale | Standard Deviation 3 |
| Placebo | Change in the Severity of Depression on the HADS Subscale. | Baseline | 8.3 score on a scale | Standard Deviation 3.8 |
| Placebo | Change in the Severity of Depression on the HADS Subscale. | After 4 weeks | 5.2 score on a scale | Standard Deviation 3 |
| Placebo | Change in the Severity of Depression on the HADS Subscale. | ∆ between baseline and 4 weeks later | 3.1 score on a scale | Standard Deviation 3.1 |
Comparison: This analysis applies to ∆ between baseline and 4 weeks later row.p-value: 0.2143Wilcoxon (Mann-Whitney)
Secondary
Change in the Severity of Depression on the HADS Subscales Within Follow-up Period.
Change in the severity of depression on the HADS subscales over a 4-week follow-up period at the end of treatment. The scale is composed of 14 statements serving 2 subscales: anxiety (odd items - 1, 3, 5, 7, 9, 11, 13) and depression (even items - 2, 4, 6, 8, 10, 12 , 14). Each statement corresponds to 4 answer options, reflecting the gradation of the severity of the sign and coded according to the increase in the severity of the symptom from 0 (no) to 3 (maximum severity). When interpreting the results, the total indicator for each subscale is taken into account, while there are 3 areas of its values: 0-7 - norm (absence of reliably expressed symptoms of anxiety and depression); 8-10 - subclinical anxiety / depression; 11 and above - clinical anxiety / depression. The depression subscale ranges from 0 to 21, with higher values reflecting a worse outcome.
Time frame: after 4 weeks of treatment and after 4 weeks of follow-up at week 8
Population: One patient in Prospekta group and three patients in Placebo group were excluded from the trial before finishing follow-up period therefore no data was collected within 4 weeks of follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prospekta | Change in the Severity of Depression on the HADS Subscales Within Follow-up Period. | After 4 weeks | 4.7 score on a scale | Standard Deviation 2.9 |
| Prospekta | Change in the Severity of Depression on the HADS Subscales Within Follow-up Period. | After 8 weeks | 3.4 score on a scale | Standard Deviation 2.6 |
| Prospekta | Change in the Severity of Depression on the HADS Subscales Within Follow-up Period. | ∆ between value after 4 weeks and after 8 weeks | 1.4 score on a scale | Standard Deviation 2.1 |
| Placebo | Change in the Severity of Depression on the HADS Subscales Within Follow-up Period. | After 4 weeks | 5.2 score on a scale | Standard Deviation 3 |
| Placebo | Change in the Severity of Depression on the HADS Subscales Within Follow-up Period. | After 8 weeks | 3.7 score on a scale | Standard Deviation 2.8 |
| Placebo | Change in the Severity of Depression on the HADS Subscales Within Follow-up Period. | ∆ between value after 4 weeks and after 8 weeks | 1.5 score on a scale | Standard Deviation 2.1 |
Comparison: This analysis applies to ∆ between value after 4 weeks and after 8 weeks row.p-value: 0.6808Wilcoxon (Mann-Whitney)
Secondary
Changes in Vital Signs (Blood Pressure).
Based on medical records. Vital signs will be measured in a medical setting.
Time frame: after 4 weeks of treatment and within 4 weeks of the follow-up period at the end of the treatment (Visit 1: baseline, Visit 2: after 4 weeks of treatment, and Visit 3: after 4 weeks of follow-up at week 8).
Population: Lower patient count is due to missing data on visits 2 and 3.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prospekta | Changes in Vital Signs (Blood Pressure). | SBP/Visit 1 | 121.3 mmHg | Standard Deviation 8.6 |
| Prospekta | Changes in Vital Signs (Blood Pressure). | SBP/Visit 2 | 121.1 mmHg | Standard Deviation 8.4 |
| Prospekta | Changes in Vital Signs (Blood Pressure). | SBP/Visit 3 | 121.1 mmHg | Standard Deviation 8.2 |
| Prospekta | Changes in Vital Signs (Blood Pressure). | DBP/Visit 1 | 75.8 mmHg | Standard Deviation 6.5 |
| Prospekta | Changes in Vital Signs (Blood Pressure). | DBP/Visit 2 | 75.8 mmHg | Standard Deviation 6.3 |
| Prospekta | Changes in Vital Signs (Blood Pressure). | DBP/Visit 3 | 76.0 mmHg | Standard Deviation 6.1 |
| Placebo | Changes in Vital Signs (Blood Pressure). | DBP/Visit 2 | 75.9 mmHg | Standard Deviation 6.3 |
| Placebo | Changes in Vital Signs (Blood Pressure). | SBP/Visit 1 | 120.9 mmHg | Standard Deviation 8.3 |
| Placebo | Changes in Vital Signs (Blood Pressure). | DBP/Visit 1 | 75.8 mmHg | Standard Deviation 6.5 |
| Placebo | Changes in Vital Signs (Blood Pressure). | SBP/Visit 2 | 120.6 mmHg | Standard Deviation 8.1 |
| Placebo | Changes in Vital Signs (Blood Pressure). | DBP/Visit 3 | 75.4 mmHg | Standard Deviation 5.9 |
| Placebo | Changes in Vital Signs (Blood Pressure). | SBP/Visit 3 | 120.4 mmHg | Standard Deviation 7.4 |
Comparison: This analysis applies to SBP/Visit1, SBP/Visit2 and SBP/Visit3 rows.p-value: 0.87Mixed Models Analysis
Comparison: This analysis applies to DBP/Visit1, DBP/Visit2 and DBP/Visit3 rows.p-value: 0.22Mixed Models Analysis
Secondary
Changes in Vital Signs (Pulse Rate (Heart Rate)).
Based on medical records. Vital signs will be measured in a medical setting.
Time frame: after 4 weeks of treatment and within 4 weeks of the follow-up period at the end of the treatment.
Population: Lower patient count is due to missing data on visits 2 and 3.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prospekta | Changes in Vital Signs (Pulse Rate (Heart Rate)). | Visit 1: baseline | 73.0 beats per minute | Standard Deviation 6.9 |
| Prospekta | Changes in Vital Signs (Pulse Rate (Heart Rate)). | Visit 2: after 4 weeks of treatment | 71.8 beats per minute | Standard Deviation 5.8 |
| Prospekta | Changes in Vital Signs (Pulse Rate (Heart Rate)). | Visit 3: after 4 weeks of follow-up at week 8 | 71.6 beats per minute | Standard Deviation 5.3 |
| Placebo | Changes in Vital Signs (Pulse Rate (Heart Rate)). | Visit 1: baseline | 73.4 beats per minute | Standard Deviation 6.9 |
| Placebo | Changes in Vital Signs (Pulse Rate (Heart Rate)). | Visit 2: after 4 weeks of treatment | 71.9 beats per minute | Standard Deviation 5.6 |
| Placebo | Changes in Vital Signs (Pulse Rate (Heart Rate)). | Visit 3: after 4 weeks of follow-up at week 8 | 71.4 beats per minute | Standard Deviation 5.5 |
p-value: 0.54Mixed Models Analysis
Secondary
Changes in Vital Signs (Respiration Rate (Breathing Rate)).
Based on medical records. Vital signs will be measured in a medical setting.
Time frame: after 4 weeks of treatment and within 4 weeks of the follow-up period at the end of the treatment (Visit 1: baseline, Visit 2: after 4 weeks of treatment, and Visit 3: after 4 weeks of follow-up at week 8)
Population: Lower patient count is due to missing data on visits 2 and 3.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prospekta | Changes in Vital Signs (Respiration Rate (Breathing Rate)). | Visit 1 | 16.3 breaths per minute | Standard Deviation 1.3 |
| Prospekta | Changes in Vital Signs (Respiration Rate (Breathing Rate)). | Visit 2 | 16.2 breaths per minute | Standard Deviation 1.2 |
| Prospekta | Changes in Vital Signs (Respiration Rate (Breathing Rate)). | Visit 3 | 16.2 breaths per minute | Standard Deviation 1.2 |
| Placebo | Changes in Vital Signs (Respiration Rate (Breathing Rate)). | Visit 1 | 16.4 breaths per minute | Standard Deviation 1.3 |
| Placebo | Changes in Vital Signs (Respiration Rate (Breathing Rate)). | Visit 2 | 16.2 breaths per minute | Standard Deviation 1.2 |
| Placebo | Changes in Vital Signs (Respiration Rate (Breathing Rate)). | Visit 3 | 16.2 breaths per minute | Standard Deviation 1.2 |
p-value: 0.49Mixed Models Analysis
Secondary
Presence of Adverse Events (AEs).
The number of participants with adverse events (AEs). Based on medical records.
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prospekta | Presence of Adverse Events (AEs). | 20 Participants |
| Placebo | Presence of Adverse Events (AEs). | 20 Participants |
p-value: 1Fisher Exact
Secondary
The Outcome of AEs.
The outcome of adverse events. Based on medical records.
Time frame: 8 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prospekta | The Outcome of AEs. | No recovery/resolution | 2 number of AEs |
| Prospekta | The Outcome of AEs. | Recovery/resolution | 22 number of AEs |
| Prospekta | The Outcome of AEs. | Unknown | 0 number of AEs |
| Placebo | The Outcome of AEs. | Recovery/resolution | 26 number of AEs |
| Placebo | The Outcome of AEs. | No recovery/resolution | 0 number of AEs |
| Placebo | The Outcome of AEs. | Unknown | 2 number of AEs |
p-value: 0.17Fisher Exact
Secondary
The Severity of AEs.
The intensity (severity) of adverse events. Based on medical records.
Time frame: 8 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prospekta | The Severity of AEs. | Moderate | 11 number of AEs |
| Prospekta | The Severity of AEs. | Mild | 13 number of AEs |
| Placebo | The Severity of AEs. | Moderate | 13 number of AEs |
| Placebo | The Severity of AEs. | Mild | 15 number of AEs |
p-value: 1Fisher Exact