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A Clinical Trial of Mycobacterium w in Critically Ill COVID 19 Patients

25. januar 2021 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Indien
      • Chandigarh, Indien, 160012
        • Postgraduate Institute of Medical Education and Research
      • Delhi, Indien, 110029
        • All lndia Institute of Medical Science, Delhi
    • Chhattisgarh
      • Raipur, Chhattisgarh, Indien, 492099
        • All India Institute of Medical Science, Raipur
    • Madhya Pradesh
      • Bhopal, Madhya Pradesh, Indien, 462024
        • All India Institute of Medical Sciences, Bhopal

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:

  • 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

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
Medicin: Suspension of heat killed (autoclaved) Mycobacterium w
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 navne:
  • Standard care of treatment for COVID-19 as per hospital practice
Placebo komparator: Standard therapy of COVID-19
0.3 ml (0.1ml x 3 Injection) of Placebo intra-dermal for 3 consecutive days
Medicin: Placebo
All patients will continue to receive standard therapy as per hospital practice till considered requisite by the treating physician
Andre navne:
  • Standard care of treatment for COVID-19 as per hospital practice

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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.
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
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.
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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of AE / SAE or event of clinical significance
Tidsramme: 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
Tidsramme: 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
Tidsramme: Till day 28
ICU length of stay
Till day 28
Duration of mechanical ventilation
Tidsramme: Till day 28
Duration of mechanical ventilation
Till day 28
Duration of hospitalization
Tidsramme: Till day 28
Duration of hospitalization
Till day 28
Clinical improvement
Tidsramme: 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
Tidsramme: Till day 28
Time (in days) from treatment initiation to death.
Till day 28
All-cause mortality
Tidsramme: Till day 28
All-cause mortality
Till day 28

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. april 2020

Primær færdiggørelse (Faktiske)

10. august 2020

Studieafslutning (Faktiske)

21. august 2020

Datoer for studieregistrering

Først indsendt

31. marts 2020

Først indsendt, der opfyldte QC-kriterier

11. april 2020

Først opslået (Faktiske)

15. april 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. januar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. januar 2021

Sidst verificeret

1. januar 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CRSC20004

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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