Clinical Trial of Mycobacterium w in COVID-19 Positive Patients, Hospitalized But Not Critically Ill
20. december 2020 opdateret af: Cadila Pharnmaceuticals
A Randomized, Double-blind, Two Arm, Controlled Clinical Trial to Compare the Efficacy and Safety of Mycobacterium w (Mw) Administered Along With Standard of Care Versus Placebo Administered Along With Standard of Care, in Adult, COVID 19 Positive Patients Hospitalized But Not Critically Ill.
This is a randomized, double blind, two arms, placebo controlled, clinical trial to study to evaluate the the safety and efficacy of Mycobacterium w in combination with standard of care versus placebo with standard of care for preventing the progression of COVID-19 disease and for reduction in transfer to ICU in COVID-19 infected patients admitted to the hospital.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Total 480 hospitalized adult eligible patients will be randomized in 1:1 ratio to receive either Mw+SOC or placebo+SOC for first 3 days post-randomization.
Daily clinical evaluation of patient will be performed till discharge from hospital or till ICU admission.
Study duration for each patient will be approximately up to 28 days, or discharge from hospital or transfer to ICU, whichever is earlier.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
480
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Bhopal, Indien
- Rekruttering
- All India Institute of Medical Sciences, Bhopal
-
Kontakt:
- Sarman Singh, MD
- Telefonnummer: 917552672317
- E-mail: director@aiimsbhopal.edu.in
-
Ledende efterforsker:
- Sarman Singh, MD
-
Chandigarh, Indien, 160012.
- Rekruttering
- Post Graduate Institute of Medical Education and Research
-
Kontakt:
- Inderpaul Singh Sehgal, DM(Pulmonary Medicine)
- Telefonnummer: 01722756823
- E-mail: inderpgi@outlook.com
-
Ledende efterforsker:
- Inderpaul Singh Sehgal, DM(Pulmonary Medicine)
-
Delhi, Indien, 110029
- Rekruttering
- All India Institute of Medical Sciences, Delhi
-
Kontakt:
- Anant Mohan, MD
- Telefonnummer: 911126588700
- E-mail: anantmohan88@gmail.com
-
Ledende efterforsker:
- Anant Mohan, MD
-
-
Chhattisgarh
-
Raipur, Chhattisgarh, Indien, 492099
- Rekruttering
- All India Institute of Medical Science, Raipur
-
Kontakt:
- Sajal De, MD
- Telefonnummer: 917712577372
- E-mail: sajalde@yahoo.com
-
Ledende efterforsker:
- Sajal De, MD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- COVID-19 positive patients with ordinal scale score of 3.
- Patients of either gender, age ≥ 18 years at the time of enrollment.
- Female patients who are currently using reliable methods of contraception (barrier methods and intrauterine contraceptive device), with a negative urine pregnancy test during screening and agree to informed compliance of contraceptive method until at least 3 months post-dosing.
- The patients must be able and willing to comply with the study protocol, available and willing to complete all the study assessments and must have signed an Informed Consent Form.
Exclusion Criteria:
- Patient with ordinal scale of ≥4 at the time of hospital admission and randomization.
- Pregnant and / or lactating female patients.
- A family history of congenital or hereditary immunodeficiency.
- Any disease condition requiring ICU admission.
- History of dialysis, silicosis, solid organ transplantation such as renal or cardiac transplants, and disorders of the heart, or nervous system, or other metabolic inflammatory conditions, psychiatric, occupational problems that make it unlikely that the patients will comply with the protocol as determined by the investigator.
- History of administration of any immunoglobulins, any immunotherapy (antineoplastic chemotherapy, radiation therapy, immunosuppressants to induce tolerance to transplants, and corticosteroids use) and/or any blood products within the 3 months preceding study dosing, or planned future administrations during the study period.
- History of allergic reactions or anaphylaxis to Mw or its component.
- Presence of any severe systemic/autoimmune disorders as determined by medical history and/or physical examination at the time of screening, which in the judgment of the Investigator would compromise the patient's health or is likely to result nonconformance to the protocol or a patient's ability to give written informed consent.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
|
Suspension of heat killed (autoclaved) Mw along with Standard of care (SOC) treatment for COVID-19
|
|
Placebo komparator: Placebo
0.3 ml (0.1ml x 3 Injection) of intradermal Placebo for 3 consecutive days + Standard therapy of COVID-19
|
Placebo along with Standard of care (SOC) treatment for COVID-19
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of patients with increased disease severity
Tidsramme: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
|
To compare the difference in proportion of patients with increased disease severity
|
From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of adverse events and serious adverse events (Safety)
Tidsramme: Till day 28
|
To evaluate safety of Mw in COVID-19 patients admitted to hospital
|
Till day 28
|
|
Number of COVID-19 patients discharged from hospital
Tidsramme: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
|
To compare the proportion of patients discharged from hospital
|
From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
|
|
Number of COVID-19 patients transfer to ICU
Tidsramme: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
|
To compare the proportion of patients transfer to ICU
|
From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
|
|
Number of COVID-19 patients with reduction in disease severity by 1 ordinal scale
Tidsramme: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
|
To compare the proportion of patients with reduction in disease severity by 1 ordinal scale
|
From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
|
|
Number of of symptom free patients
Tidsramme: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
|
To compare the proportion of symptom free patients
|
From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Sanjay Patel, MBBS, Cadila Pharmaceuticals Limited
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
30. juni 2020
Primær færdiggørelse (Forventet)
28. februar 2021
Studieafslutning (Forventet)
30. april 2021
Datoer for studieregistrering
Først indsendt
21. april 2020
Først indsendt, der opfyldte QC-kriterier
21. april 2020
Først opslået (Faktiske)
24. april 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. december 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. december 2020
Sidst verificeret
1. december 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CRSC20006
Plan for individuelle deltagerdata (IPD)
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