COVID-19
Conditions
Brief summary
The trial is randomized, blinded, two arms, active comparator controlled, clinical trial to evaluate the safety and efficacy of Mycobacterium w in combination with standard care as per hospital practice versus standard care alone in critically ill adult patients suffering from COVID-19 infection.
Detailed description
In this study, Eligible patients will be enrolled after due consent and will be randomized in balance to receive either test drug (along with the standard of care) or Placebo (along with the standard of care). The enrolled patients will be monitored for any adverse events (AEs) or serious adverse events (SAEs) throughout the study period. All patients will continue to receive standard therapy till considered requisite by the treating physician. In addition to the standard care for COVID-19, patients randomized to test arm will receive single daily dose of 0.3 ml of Mw, intradermal, for 3 consecutive days while patients randomized to control arm will receive single daily dose of 0.3 ml of Placebo, intradermal, for 3 consecutive days. Study duration for each patient will be upto 28 days post-randomization.
Interventions
Patients will be randomized to receive either Mycobacterium w in combination with standard care as per hospital practice or standard care alone in COVID-19 as per hospital practice.
DRUGPlacebo
All patients will continue to receive standard therapy as per hospital practice till considered requisite by the treating physician
Sponsors
Council of Scientific and Industrial Research, India
Cadila Pharnmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Investigator, patient and study staff will be blinded to the study treatment.
Intervention model description
Randomized, blinded, two arms, active comparator controlled, clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Critically ill patients infected with COVID-19 (clinical/confirmed) * Patient aged 18 years or more of either gender * Illness of any duration with respiratory rate ≥25 breaths/minute, and at least one of the following: * Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or or * SpO2 ≤94% on room air, or * Requiring mechanical ventilation and/or supplemental oxygen * Female patients of childbearing potential must have a negative pregnancy test within 14 days prior to first dose of study medication. * Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedure.
Exclusion criteria
* Pregnant or nursing female. * Patients with history of allergy, hypersensitivity, or any serious reaction to study medication * Patients with a concomitant medical condition, whose participation, in the opinion of the investigator, may create an unacceptable additional risk. * Patient previously enrolled into this study. * Patient participating or having participated in a clinical trial with another investigational drug within the last 28 days except for investigational drugs against cancer, leukaemia or HIV. * Patients with a life expectancy judged to be less than five days * ALT/AST \> 5 times the upper limit of normal * Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR \< 30) * Patients not likely to complete the trial as per judgment of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death) | Change in Ordinal scale from baseline to day 3, day 7, day 14, day 21 and day 28 and day of transfer from ICU, if discharged earlier than 28 days post-randomization. | To study the effect of Mw on recovery of organ function as assessed by Ordinal scale |
| Sequential Organ Failure Assessment (SOFA) scores | Change in SOFA score from baseline to day 3, day 7, day 14, day 21 and day 28 and day of transfer from ICU, if discharged earlier than 28 days post-randomization. | To study the effect of Mw on recovery of organ function as assessed by Sequential Organ Failure Assessment (SOFA) which is based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU length of stay | Till day 28 | ICU length of stay |
| Duration of mechanical ventilation | Till day 28 | Duration of mechanical ventilation |
| Duration of hospitalization | Till day 28 | Duration of hospitalization |
| Incidence of AE / SAE or event of clinical significance | Till day 28 | Any AE / SAE or event of clinical significance observed during the study. |
| Time (in days) from treatment initiation to death | Till day 28 | Time (in days) from treatment initiation to death. |
| All-cause mortality | Till day 28 | All-cause mortality |
| Clinical improvement | From baseline to day 14 & Day 28 | Percentage of subjects having clinical improvement defined as two-point improvement on a seven category ordinal scale. |
| SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample | At days 3, 7, 14, 21, and 28 | Percent of subjects with SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample. |
Countries
India
Outcome results
None listed