COVID-19 Prevention and Treatment in Cancer; a Sequential Multiple Assignment Randomised Trial;

Sponsor
Peter MacCallum Cancer Centre, Australia
Study ID
NCT04534725
Phase
PHASE3
Status
Completed

Conditions

  • Cancer
  • Covid19
  • Respiratory Viral Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Interferon alfa — DRUG
    intranasal spray
  • Selinexor — DRUG
    oral tablet
  • Lenzilumab — DRUG
    intravenous infusion

Study Details

A multi-centre Australian trial with four arms aims to evaluate several different immune modulating drugs for prevention and treatment of COVID-19 specifically in the cancer population. ARM 1 is evaluating the effect of interferon-alpha (vs placebo) on the incidence of COVID-19 infection in cancer patients with no COVID-19 infection or no known COVID-19 positive contacts. ARM 2 is evaluating the effect of interferon-alpha (vs placebo) on the incidence of COVID-19 infection in cancer patients with confirmed exposure to COVID-19 virus. ARM 3 is evaluating the effect of Selinexor (vs placebo) on the incidence of COVID-19 infection in cancer patients with moderate COVID-19 infection. ARM 4 is evaluating the effect of Lenzilumab (vs placebo) on the treatment of COVID-19 infection in cancer patients with severe COVID-19 infection. Participants may become eligible and transition to different arms and treatments if they become exposed to COVID-19 or are hospitalised with an active moderate/severe COVID-19 infection. It is hoped this research will provide insight into the best practice for prevention and treatment of COVID-19 in cancer patients as emerging standard of care measures are not always suitable to this especially vulnerable population.

Key Dates

Start date
Dec 17, 2020
Status verified
Aug 2023
Primary completion
Nov 28, 2022
Completion
Apr 19, 2023

Study Design

Enrollment
441 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: prophylaxis
    This study arm (arm 1) is evaluating the effect of interferon-alpha on the incidence of COVID-19 infection in cancer patients with no COVID-19 infection or no known COVID-19 positive contacts. Participants in this study arm are randomly allocated (by chance) to one of two groups. One group will receive daily interferon-alpha intranasal spray for 3 months while the other group will receive a daily placebo intranasal spray for 3 months. Participants will be followed during the 3-month treatment for incidence of COVID-19 and other respiratory infections.
  • Experimental: Post-Exposure Prophylaxis
    This study arm (arm 2) is evaluating the effect of interferon-alpha on the incidence of COVID-19 infection in cancer patients with confirmed exposure to COVID-19 virus. Participants in this study arm are randomly allocated (by chance) to one of two groups. One group will receive daily interferon-alpha intranasal spray for 7 days (at a higher dose than arm 1) while the other group will receive a daily placebo intranasal spray for 7 days Participants will be followed for 28 days for incidence of COVID-19 and other respiratory infections.
  • Experimental: Moderate COVID-19 infection
    This study arm (arm 3) is evaluating the effect of Selinexor on the incidence of COVID-19 infection in cancer patients with moderate COVID-19 infection. Participants in this study arm are randomly allocated (by chance) to one of two groups. One group will receive oral Selinexor 3 times a week for 2 weeks while the other group will receive oral placebo 3 times a week for 2 weeks Participants will be followed for 60 days to assess effectiveness and safety.
  • Experimental: Severe COVID-19 infection
    This study arm (arm 4) is evaluating the effect of Lenzilumab on the treatment of COVID-19 infection in cancer patients with severe COVID-19 infection. Participants in this study arm are randomly allocated (by chance) to one of two groups. One group will receive intravenous Lenzilumab over 24 hours while the other group will receive placebo intravenously over 24 hours. Participants will be followed for 60 days to assess effectiveness and safety.

Primary Outcome Measure

Incidence of COVID-19 in cancer patients using interferon-alpha as prophylaxis without known positive contact with COVID-19 (COVID-19 confirmed by qPCR from respiratory swab) [ Time Frame: 3 months from baseline. ]

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