A Clinical Trial of Mycobacterium w in Critically Ill COVID 19 Patients
25 januari 2021 uppdaterad av: Cadila Pharnmaceuticals
A Clinical Trial to Evaluate the Safety and Efficacy of Mycobacterium W in Critically Ill Patients Suffering From COVID 19 Infection
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
40
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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Chandigarh, Indien, 160012
- Postgraduate Institute of Medical Education and Research
-
Delhi, Indien, 110029
- All lndia Institute of Medical Science, Delhi
-
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Chhattisgarh
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Raipur, Chhattisgarh, Indien, 492099
- All India Institute of Medical Science, Raipur
-
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Madhya Pradesh
-
Bhopal, Madhya Pradesh, Indien, 462024
- All India Institute of Medical Sciences, Bhopal
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Suspension of Mw + Standard therapy of COVID-19
0.3 ml (0.1ml x 3 Injection) of intradermal Mw for 3 consecutive days + Standard therapy of COVID-19 |
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.
Andra namn:
|
|
Placebo-jämförare: Standard therapy of COVID-19
0.3 ml (0.1ml x 3 Injection) of Placebo intra-dermal for 3 consecutive days
|
All patients will continue to receive standard therapy as per hospital practice till considered requisite by the treating physician
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death)
Tidsram: 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
|
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.
|
|
Sequential Organ Failure Assessment (SOFA) scores
Tidsram: 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
|
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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of AE / SAE or event of clinical significance
Tidsram: Till day 28
|
Any AE / SAE or event of clinical significance observed during the study.
|
Till day 28
|
|
SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample
Tidsram: At days 3, 7, 14, 21, and 28
|
Percent of subjects with SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample.
|
At days 3, 7, 14, 21, and 28
|
|
ICU length of stay
Tidsram: Till day 28
|
ICU length of stay
|
Till day 28
|
|
Duration of mechanical ventilation
Tidsram: Till day 28
|
Duration of mechanical ventilation
|
Till day 28
|
|
Duration of hospitalization
Tidsram: Till day 28
|
Duration of hospitalization
|
Till day 28
|
|
Clinical improvement
Tidsram: From baseline to day 14 & Day 28
|
Percentage of subjects having clinical improvement defined as two-point improvement on a seven category ordinal scale.
|
From baseline to day 14 & Day 28
|
|
Time (in days) from treatment initiation to death
Tidsram: Till day 28
|
Time (in days) from treatment initiation to death.
|
Till day 28
|
|
All-cause mortality
Tidsram: Till day 28
|
All-cause mortality
|
Till day 28
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studiestol: Anil Avhad, MBBS, Cadila Pharmaceuticals Limited
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
30 april 2020
Primärt slutförande (Faktisk)
10 augusti 2020
Avslutad studie (Faktisk)
21 augusti 2020
Studieregistreringsdatum
Först inskickad
31 mars 2020
Först inskickad som uppfyllde QC-kriterierna
11 april 2020
Första postat (Faktisk)
15 april 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
27 januari 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 januari 2021
Senast verifierad
1 januari 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CRSC20004
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
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Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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