Clinical Trial to Evaluate Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19
20 december 2020 uppdaterad av: Cadila Pharnmaceuticals
A Randomized, Double-blind, Two Arm, Placebo Controlled Clinical Trial to Evaluate the Efficacy and Safety of Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19.
This clinical trial is a randomized, blinded, two arms, placebo controlled, clinical trial to evaluate the safety and efficacy of Mycobacterium w in combination with standard care as per hospital practice to prevent COVID 19 in subjects at risk of getting infected with COVID 19.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Approximately eligible 4000 subjects who are at risk of getting infected with COVID-19 (i.e. person living in same household as COVID-19 patients / healthcare workers providing direct care to COVID-19 patients) will be enrolled in to the study after due consent and based on the eligibility criteria.
Initially, 400 subjects at risk of getting infected with COVID-19 will be enrolled in the study and randomized in 1:1 ratio to receive either Mw (n=200) or placebo (n=200). After the interim analysis from the data of these 400 subjects for safety and efficacy and based on review and recommendations from DSMB / MC, modification in study design, objective or sample size will be considered.
Study duration for each subject will be of 8 weeks.
Studietyp
Interventionell
Inskrivning (Förväntat)
4000
Fas
- Fas 3
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.
- Rekrytering
- Post Graduate Institute of Medical Education and Research
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Kontakt:
- Inderpaul Singh Sehgal, DM (Pulmonary Medicine)
- Telefonnummer: 01722756823
- E-post: inderpgi@outlook.com
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Huvudutredare:
- Inderpaul Singh Sehgal, DM (Pulmonary Medicine)
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Delhi, Indien, 110029
- Rekrytering
- All lndia Institute of Medical Science, Delhi
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Kontakt:
- Sushma Bhatnagar, MD (Anaesthesiology)
- Telefonnummer: 919811326453
- E-post: sushmabhatnagar1@gmail.com
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Huvudutredare:
- Sushma Bhatnagar, MD (Anaesthesiology)
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Madhya Pradesh
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Bhopal, Madhya Pradesh, Indien, 462024
- Rekrytering
- All India Institute of Medical Sciences, Bhopal
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Kontakt:
- Sarman Singh, MD
- Telefonnummer: 917552672317
- E-post: director@aiimsbhopal.edu.in
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Huvudutredare:
- Sarman Singh, MD
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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
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Healthy subjects of either gender, age ≥ 18 years, with recent history of close contact with COVID-19 patients.
- Subjects with SARS Cov 2 negative test (ICMR approved test kit) at screening visit.
- Female subject 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 months post-dosing.
- The subject 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:
- Any febrile illness with oral temperature > 100°F within 3 days prior to randomization.
- Subject with past history of COVID-19 infection.
- Pregnant and / or lactating female subjects.
- Presence of any illness requiring hospital referral.
- Any confirmed or suspected immune-deficient condition based on medical history and physical examination and a family history of congenital or hereditary immunodeficiency or Individuals on immunosuppressant's as Azathioprine, Cyclosporine, Mycophenolate etc.
- History of allergic reactions or anaphylaxis to Mw or its component.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Suspension of Mw
Intradermal suspension of Mw will be administered in two divided doses: Dose 1 at Day 0: 0.2 ml (0.1 ml x 2 injection) of intradermal Mw in two divided dose. Dose 2 at Day 15 after the first dose: 0.1 ml injection of intradermal Mw administered. |
Subjects randomized to Test arm will receive intraderma Mw in divided doses at least 2 cm away from first injection site in the deltoid region.
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Placebo-jämförare: Placebo
Placebo will be administered in two divided doses: Dose 1 at Day 0: 0.2 ml (0.1 ml x 2 injection) of intradermal placebo in two divided dose. Dose 2 at Day 15 after the first dose: 0.1 ml injection of intradermal placebo. |
Subjects randomized to placebo arm will receive intraderma Placebo in divided doses at least 2 cm away from first injection site in the deltoid region.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of subject acquiring COVID-19 infection
Tidsram: From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing..
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To compare proportion of subjects acquiring COVID-19 infection between two arms over the time till 8 weeks from administration of 1st dose
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From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing..
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Incidence of Adverse Event and Serious Adverse Event (safety and tolerability)
Tidsram: Till 8 weeks
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Any AE / SAE observed during the study.
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Till 8 weeks
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Number of subject developing Upper Respiratory Tract Infection (URTI) symptoms
Tidsram: From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing.
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Whether administration of Mw prevents development of Upper Respiratory Tract Infection (URTI) symptoms in close contacts of COVID-19 patients.
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From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing.
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Number of subject developing severe COVID-19 infection based on ordinal scale
Tidsram: From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing
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Whether administration of Mw prevents development of severe COVID-19 infection.
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From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing
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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 juni 2020
Primärt slutförande (Förväntat)
30 mars 2021
Avslutad studie (Förväntat)
30 maj 2021
Studieregistreringsdatum
Först inskickad
16 april 2020
Först inskickad som uppfyllde QC-kriterierna
16 april 2020
Första postat (Faktisk)
20 april 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
22 december 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 december 2020
Senast verifierad
1 april 2020
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CRSC20005
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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