Post-acute Covid-19 Syndrome
Conditions
Keywords
Long Covid
Brief summary
To determine whether an individually prescribed homeopathic medicine has an effect greater than a placebo and is a viable treatment option to improve fatigue and quality of life for patients suffering from the symptoms of Post-acute COVID-19 Syndrome. The researchers hope to achieve this goal by conducting a clinical trial that is scientifically rigorous and clinically relevant. Expected results of this pilot study will be to obtain sufficient experience and preliminary feasibility data to justify a larger clinical trial of this hypothesis.
Detailed description
The researchers objectives for the study are to: 1) identify efficient means of recruiting subjects, 2) test and refine the initial study design and treatment protocol, 3) evaluate the instruments for assessing treatment outcomes, 4) estimate sample sizes that will be required in the full-scale trial, 5) determine which homeopathic medicines are most often prescribed for this syndrome, and 6) determine whether there is a measurable effect size difference or positive trend in reduction of symptoms in patients treated with homeopathy.
Interventions
Homeopathic medicines are prepared according to standardized methods as specified by the Homeopathic Pharmacopoeia of the United States (HPUS), which was mandated by Congress to regulate the manufacture of homeopathic medicines as part of the Food, Drug, and Cosmetics Act of 1939. All homeopathic medicines prescribed in this study must be found in the HPUS. For a complete list of homeopathic medicines, contact the researchers.
OTHERPlacebo
Inert lactose pellets
Sponsors
Samueli Institute for Information Biology
Southwest College of Naturopathic Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Both study medication and placebo are identical in appearance, odor, and taste. Statistician will be blinded as to treatment group.
Intervention model description
Randomized, double-blind, placebo-controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Ages 18-64 * Any ethnicity * Adequate cognitive function to be able to give informed consent * Technologically competent to complete web forms and perform video calls * Positive PCR test (polymerase chain reaction) result for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) * Persistent fatigue for a minimum of 60 days since diagnosis of Covid-19. * A fatigue score above 21 in the Fatigue Assessment Scale upon enrollment * Willing to fill out regular questionnaires * Willing to use homeopathic medicines
Exclusion criteria
* Clinically significant kidney, heart, or hepatic impairment as determined by clinical judgment * Previous hospitalization in ICU for Covid-19 * Diagnosis of Chronic Fatigue Syndrome, Fibromyalgia, or Lyme disease prior to Covid-19 * Chronic psychiatric illness or neurological illness prior to Covid-19 diagnosis Taking opioid analgesics, opioid dependence or undergoing treatment for substance abuse or addiction * Taking steroid medication or immunosuppressive medications * Suspected or confirmed pregnancy or breastfeeding * Active cancers * Current treatment by a homeopathic practitioner * Initiation of another treatment for Long Covid within the past 2 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Assessment Scale (FAS) | Baseline, 4, 8 and 12 weeks | The Fatigue Assessment Scale (FAS) is a 10-item self-report scale evaluating symptoms of chronic fatigue. The total score ranges from 10 to 50, with a higher score indicating more severe fatigue. Less than 22 indicates normal (i.e. healthy) levels of fatigue between 22 and 34 indicates mild-to-moderate fatigue 35 or more indicates severe fatigue (Hendricks et al., 2018). |
| SF-36 Physical Composite Score (PCS) | Baseline and 4, 8, and 12 weeks | Quality of life was evaluated by using the the RAND 36-Item Short Form Health Survey (SF-36), which was completed by participants throughout the study. The SF-36 evaluates 8 health concepts and can be aggregated into two summary scores: the Physical (PCS) and Mental (MCS) Component Summary scores. Each item of the scale ranges from 0-100, where high values mean good health status, while lower values indicate poor health status. Items are averaged together to create PCS or MCS scale scores. |
| SF-36 Mental Composite Score (MCS) | Baseline and 4, 8, and 12 weeks | Quality of life was evaluated by using the the RAND 36-Item Short Form Health Survey (SF-36), which was completed by participants throughout the study. The SF-36 evaluates 8 health concepts and can be aggregated into two summary scores: the Physical (PCS) and Mental (MCS) Component Summary scores. Each item of the scale ranges from 0-100, where high values mean good health status, while lower values indicate poor health status. Items are averaged together to create PCS or MCS scale scores.  |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-9 (PHQ-9) | Baseline and 12 weeks | The Patient Health Questionnaire-9 (PHQ-9) is a self-administered tool for assessing depression The PHQ-9 scores each of the 9 DSM-IV depression criteria as 0 (not at all) to 3 (nearly every day). PHQ-9 scores range from 0 to 27, with scores of 5, 10, 15, and 20 representing mild, moderate, moderately severe, and severe depression, respectively. |
| Patient Doctor Depth of Relationship (PDDR) | 12 weeks | The Patient Doctor Depth of Relationship (PDDR) scale is an eight item, patient self-completed questionnaire designed to measure patient-doctor relational depth. A single overall depth-of-relationship score can be calculated, which ranges from 0 (no relationship) to 32 (very strong relationship). |
| Measure Yourself Medical Outcomes Profile Symptom #1 | Baseline and 12 weeks | The Measure Yourself Medical Outcomes Profile (MYMOP) is a problem specific and individualized measure that captures what patients consider are the two most important symptoms associated with their condition (Long COVID) and an activity of daily living that is affected by these symptoms. The symptom is then rated by the patient on a scale 0-6 where higher values mean poor health and lower values indicate good health. |
| Measure Yourself Medical Outcomes Profile Symptom #2 | Baseline and 12 weeks | The Measure Yourself Medical Outcomes Profile (MYMOP) is a problem specific and individualized measure that captures what patients consider are the two most important symptoms associated with their condition (Long COVID) and an activity of daily living that is affected by these symptoms. The symptom is then rated by the patient on a scale 0-6 where higher values mean poor health and lower values indicate good health. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Homeopathic Treatment Group Long Covid patients received individualized homeopathic treatment with homeopathic medicines. Dosage and frequency of administration was determined by each provider on an individualized basis. | 38 |
| Placebo Group Long Covid patients received placebo homeopathic medicines (i.e. identical lactose pellets in size, odor, and taste without the impregnated homeopathic medicines) | 39 |
| Total | 77 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 3 |
Baseline characteristics
| Characteristic | Total | Homeopathic Treatment Group | Placebo Group |
|---|---|---|---|
| Age, Continuous | 42.9 years STANDARD_DEVIATION 9.9 | 41.4 years STANDARD_DEVIATION 8.3 | 44.4 years STANDARD_DEVIATION 11.1 |
| Baseline Score in Fatigue Assessment Scale | 35.1 score on a scale STANDARD_DEVIATION 7 | 34.4 score on a scale STANDARD_DEVIATION 7.1 | 35.8 score on a scale STANDARD_DEVIATION 6.8 |
| Baseline Score in MYMOP Symptom #1 | 4.5 score on a scale STANDARD_DEVIATION 1.1 | 4.6 score on a scale STANDARD_DEVIATION 1.2 | 4.5 score on a scale STANDARD_DEVIATION 1 |
| Baseline Score in MYMOP Symptom #2 | 4.4 score on a scale STANDARD_DEVIATION 1 | 4.4 score on a scale STANDARD_DEVIATION 1 | 4.4 score on a scale STANDARD_DEVIATION 1 |
| Baseline Score in PHQ-9 | 11.8 score on a scale STANDARD_DEVIATION 5.4 | 12.8 score on a scale STANDARD_DEVIATION 5.6 | 10.8 score on a scale STANDARD_DEVIATION 5.1 |
| Baseline Score in SF-36 Mental Combined score (MCS) | 36.6 score on a scale STANDARD_DEVIATION 17.4 | 35.7 score on a scale STANDARD_DEVIATION 18.3 | 37.6 score on a scale STANDARD_DEVIATION 16.7 |
| Baseline Score in SF-36 Physical Composite Score (PCS) | 44.3 score on a scale STANDARD_DEVIATION 18.9 | 45.8 score on a scale STANDARD_DEVIATION 17.4 | 42.9 score on a scale STANDARD_DEVIATION 20.4 |
| BMI | 26.9 kg/m^2 STANDARD_DEVIATION 6.5 | 27.6 kg/m^2 STANDARD_DEVIATION 7.8 | 26.2 kg/m^2 STANDARD_DEVIATION 4.8 |
| Duration of Long Covid Symptoms | 266.2 Days STANDARD_DEVIATION 146.6 | 246.4 Days STANDARD_DEVIATION 141 | 285.5 Days STANDARD_DEVIATION 151.1 |
| Education Status Bachelor's Degree | 29 Participants | 17 Participants | 12 Participants |
| Education Status High School | 1 Participants | 0 Participants | 1 Participants |
| Education Status Master's Degree | 17 Participants | 8 Participants | 9 Participants |
| Education Status PhD or higher | 2 Participants | 1 Participants | 1 Participants |
| Education Status Some college | 28 Participants | 12 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 72 Participants | 34 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 4 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hospitalization Rate for Acute Covid-19 Infection | 9 Participants | 3 Participants | 6 Participants |
| Number of Long Covid Booster Participants | 25 Participants | 11 Participants | 14 Participants |
| Number of Medications 1-2 | 22 Participants | 10 Participants | 12 Participants |
| Number of Medications 3 or more | 25 Participants | 13 Participants | 12 Participants |
| Number of Medications Zero | 30 Participants | 15 Participants | 15 Participants |
| Number of Supplements 1-4 | 31 Participants | 17 Participants | 14 Participants |
| Number of Supplements 5 or more | 30 Participants | 16 Participants | 14 Participants |
| Number of Supplements Zero | 16 Participants | 5 Participants | 11 Participants |
| Number of Vaccinated Participants | 59 Participants | 29 Participants | 30 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 69 Participants | 34 Participants | 35 Participants |
| Sex: Female, Male Female | 62 Participants | 31 Participants | 31 Participants |
| Sex: Female, Male Male | 15 Participants | 7 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 39 |
| other Total, other adverse events | 6 / 38 | 6 / 39 |
| serious Total, serious adverse events | 0 / 38 | 2 / 39 |
Outcome results
Primary
Fatigue Assessment Scale (FAS)
The Fatigue Assessment Scale (FAS) is a 10-item self-report scale evaluating symptoms of chronic fatigue. The total score ranges from 10 to 50, with a higher score indicating more severe fatigue. Less than 22 indicates normal (i.e. healthy) levels of fatigue between 22 and 34 indicates mild-to-moderate fatigue 35 or more indicates severe fatigue (Hendricks et al., 2018).
Time frame: Baseline, 4, 8 and 12 weeks
Population: All patients under randomization were included (intention-to-treat population) regardless whether or not they adhered to the treatment protocol or provided complete data sets.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Homeopathic Treatment Group | Fatigue Assessment Scale (FAS) | 4 Weeks | 32.9 score on a scale | Standard Deviation 7.6 |
| Homeopathic Treatment Group | Fatigue Assessment Scale (FAS) | 12 Weeks | 29.4 score on a scale | Standard Deviation 9.1 |
| Homeopathic Treatment Group | Fatigue Assessment Scale (FAS) | 8 Weeks | 29.0 score on a scale | Standard Deviation 8 |
| Placebo Group | Fatigue Assessment Scale (FAS) | 4 Weeks | 31.4 score on a scale | Standard Deviation 7.7 |
| Placebo Group | Fatigue Assessment Scale (FAS) | 8 Weeks | 27.4 score on a scale | Standard Deviation 9.4 |
| Placebo Group | Fatigue Assessment Scale (FAS) | 12 Weeks | 27.3 score on a scale | Standard Deviation 10 |
Primary
SF-36 Mental Composite Score (MCS)
Quality of life was evaluated by using the the RAND 36-Item Short Form Health Survey (SF-36), which was completed by participants throughout the study. The SF-36 evaluates 8 health concepts and can be aggregated into two summary scores: the Physical (PCS) and Mental (MCS) Component Summary scores. Each item of the scale ranges from 0-100, where high values mean good health status, while lower values indicate poor health status. Items are averaged together to create PCS or MCS scale scores. 
Time frame: Baseline and 4, 8, and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Homeopathic Treatment Group | SF-36 Mental Composite Score (MCS) | Week 4 | 43.0 score on a scale | Standard Deviation 21.6 |
| Homeopathic Treatment Group | SF-36 Mental Composite Score (MCS) | Week 8 | 47.8 score on a scale | Standard Deviation 22 |
| Homeopathic Treatment Group | SF-36 Mental Composite Score (MCS) | Week 12 | 49.8 score on a scale | Standard Deviation 23.4 |
| Placebo Group | SF-36 Mental Composite Score (MCS) | Week 4 | 50.2 score on a scale | Standard Deviation 21.7 |
| Placebo Group | SF-36 Mental Composite Score (MCS) | Week 8 | 54.7 score on a scale | Standard Deviation 24.8 |
| Placebo Group | SF-36 Mental Composite Score (MCS) | Week 12 | 57.3 score on a scale | Standard Deviation 25.7 |
Primary
SF-36 Physical Composite Score (PCS)
Quality of life was evaluated by using the the RAND 36-Item Short Form Health Survey (SF-36), which was completed by participants throughout the study. The SF-36 evaluates 8 health concepts and can be aggregated into two summary scores: the Physical (PCS) and Mental (MCS) Component Summary scores. Each item of the scale ranges from 0-100, where high values mean good health status, while lower values indicate poor health status. Items are averaged together to create PCS or MCS scale scores.
Time frame: Baseline and 4, 8, and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Homeopathic Treatment Group | SF-36 Physical Composite Score (PCS) | 4 Weeks | 51.8 score on a scale | Standard Deviation 18.2 |
| Homeopathic Treatment Group | SF-36 Physical Composite Score (PCS) | 8 Weeks | 55.0 score on a scale | Standard Deviation 22.6 |
| Homeopathic Treatment Group | SF-36 Physical Composite Score (PCS) | 12 Weeks | 55.0 score on a scale | Standard Deviation 23.1 |
| Placebo Group | SF-36 Physical Composite Score (PCS) | 4 Weeks | 51.1 score on a scale | Standard Deviation 22.3 |
| Placebo Group | SF-36 Physical Composite Score (PCS) | 8 Weeks | 58.7 score on a scale | Standard Deviation 26.5 |
| Placebo Group | SF-36 Physical Composite Score (PCS) | 12 Weeks | 61.2 score on a scale | Standard Deviation 27.4 |
Secondary
Measure Yourself Medical Outcomes Profile Symptom #1
The Measure Yourself Medical Outcomes Profile (MYMOP) is a problem specific and individualized measure that captures what patients consider are the two most important symptoms associated with their condition (Long COVID) and an activity of daily living that is affected by these symptoms. The symptom is then rated by the patient on a scale 0-6 where higher values mean poor health and lower values indicate good health.
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Homeopathic Treatment Group | Measure Yourself Medical Outcomes Profile Symptom #1 | 1.3 score on a scale | Standard Deviation 1.9 |
| Placebo Group | Measure Yourself Medical Outcomes Profile Symptom #1 | 1.6 score on a scale | Standard Deviation 1.8 |
Secondary
Measure Yourself Medical Outcomes Profile Symptom #2
The Measure Yourself Medical Outcomes Profile (MYMOP) is a problem specific and individualized measure that captures what patients consider are the two most important symptoms associated with their condition (Long COVID) and an activity of daily living that is affected by these symptoms. The symptom is then rated by the patient on a scale 0-6 where higher values mean poor health and lower values indicate good health.
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Homeopathic Treatment Group | Measure Yourself Medical Outcomes Profile Symptom #2 | 1.0 score on a scale | Standard Deviation 1.7 |
| Placebo Group | Measure Yourself Medical Outcomes Profile Symptom #2 | 1.7 score on a scale | Standard Deviation 1.6 |
Secondary
Patient Doctor Depth of Relationship (PDDR)
The Patient Doctor Depth of Relationship (PDDR) scale is an eight item, patient self-completed questionnaire designed to measure patient-doctor relational depth. A single overall depth-of-relationship score can be calculated, which ranges from 0 (no relationship) to 32 (very strong relationship).
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Homeopathic Treatment Group | Patient Doctor Depth of Relationship (PDDR) | 24.1 score on a scale | Standard Deviation 6.4 |
| Placebo Group | Patient Doctor Depth of Relationship (PDDR) | 24.3 score on a scale | Standard Deviation 6.1 |
Secondary
Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) is a self-administered tool for assessing depression The PHQ-9 scores each of the 9 DSM-IV depression criteria as 0 (not at all) to 3 (nearly every day). PHQ-9 scores range from 0 to 27, with scores of 5, 10, 15, and 20 representing mild, moderate, moderately severe, and severe depression, respectively.
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Homeopathic Treatment Group | Patient Health Questionnaire-9 (PHQ-9) | 7.8 score on a scale | Standard Deviation 5.7 |
| Placebo Group | Patient Health Questionnaire-9 (PHQ-9) | 6.8 score on a scale | Standard Deviation 4.8 |