A Clinical Trial of Mycobacterium w in Critically Ill COVID 19 Patients
25. januar 2021 oppdatert 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
40
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Chandigarh, India, 160012
- Postgraduate Institute of Medical Education and Research
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Delhi, India, 110029
- All lndia Institute of Medical Science, Delhi
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Chhattisgarh
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Raipur, Chhattisgarh, India, 492099
- All India Institute of Medical Science, Raipur
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Madhya Pradesh
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Bhopal, Madhya Pradesh, India, 462024
- All India Institute of Medical Sciences, Bhopal
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
Andre navn:
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Placebo komparator: 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
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death)
Tidsramme: 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.
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To study the effect of Mw on recovery of organ function as assessed by Ordinal scale
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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.
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Sequential Organ Failure Assessment (SOFA) scores
Tidsramme: 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.
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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
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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.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of AE / SAE or event of clinical significance
Tidsramme: Till day 28
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Any AE / SAE or event of clinical significance observed during the study.
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Till day 28
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SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample
Tidsramme: At days 3, 7, 14, 21, and 28
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Percent of subjects with SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample.
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At days 3, 7, 14, 21, and 28
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ICU length of stay
Tidsramme: Till day 28
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ICU length of stay
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Till day 28
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Duration of mechanical ventilation
Tidsramme: Till day 28
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Duration of mechanical ventilation
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Till day 28
|
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Duration of hospitalization
Tidsramme: Till day 28
|
Duration of hospitalization
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Till day 28
|
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Clinical improvement
Tidsramme: From baseline to day 14 & Day 28
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Percentage of subjects having clinical improvement defined as two-point improvement on a seven category ordinal scale.
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From baseline to day 14 & Day 28
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Time (in days) from treatment initiation to death
Tidsramme: Till day 28
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Time (in days) from treatment initiation to death.
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Till day 28
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All-cause mortality
Tidsramme: Till day 28
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All-cause mortality
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Till day 28
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Anil Avhad, MBBS, Cadila Pharmaceuticals Limited
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
30. april 2020
Primær fullføring (Faktiske)
10. august 2020
Studiet fullført (Faktiske)
21. august 2020
Datoer for studieregistrering
Først innsendt
31. mars 2020
Først innsendt som oppfylte QC-kriteriene
11. april 2020
Først lagt ut (Faktiske)
15. april 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. januar 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. januar 2021
Sist bekreftet
1. januar 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CRSC20004
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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