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Clinical Trial to Evaluate Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19

20. december 2020 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

4000

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Indien
      • 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 lndia Institute of Medical Science, Delhi
        • Kontakt:
        • Ledende efterforsker:
          • Sushma Bhatnagar, MD (Anaesthesiology)
    • Madhya Pradesh
      • Bhopal, Madhya Pradesh, Indien, 462024
        • Rekruttering
        • All India Institute of Medical Sciences, Bhopal
        • Kontakt:
        • Ledende efterforsker:
          • Sarman Singh, 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

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: Suspension of heat killed (autoclaved) Mycobacterium w
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.
Placebo komparator: 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of subject acquiring COVID-19 infection
Tidsramme: 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..
To compare proportion of subjects acquiring COVID-19 infection between two arms over the time till 8 weeks from administration of 1st dose
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..

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Adverse Event and Serious Adverse Event (safety and tolerability)
Tidsramme: Till 8 weeks
Any AE / SAE observed during the study.
Till 8 weeks
Number of subject developing Upper Respiratory Tract Infection (URTI) symptoms
Tidsramme: 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.
Whether administration of Mw prevents development of Upper Respiratory Tract Infection (URTI) symptoms in close contacts of COVID-19 patients.
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.
Number of subject developing severe COVID-19 infection based on ordinal scale
Tidsramme: 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
Whether administration of Mw prevents development of severe COVID-19 infection.
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cadila Pharnmaceuticals

Samarbejdspartnere

Council of Scientific and Industrial Research, India

Efterforskere

  • Studiestol: Anil Avhad, 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)

30. marts 2021

Studieafslutning (Forventet)

30. maj 2021

Datoer for studieregistrering

Først indsendt

16. april 2020

Først indsendt, der opfyldte QC-kriterier

16. april 2020

Først opslået (Faktiske)

20. april 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. december 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. december 2020

Sidst verificeret

1. april 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CRSC20005

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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