Checkpoint Blockade in COVID-19 Pandemic

Sponsor
MedSIR
Study ID
NCT04335305
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    IV infusion over 60 minutes; 8 mg/kg (up to a maximum of 800 mg per dose); single dose
  • Pembrolizumab (MK-3475) — BIOLOGICAL
    IV infusion over 30 minutes, 200 mg; single dose

Study Details

This is a prospective, multicenter, randomized, controlled, open-label, phase 2 clinical trial

Key Dates

Start date
Apr 9, 2020
Status verified
Jun 2022
Primary completion
Mar 8, 2021
Completion
Jun 21, 2021

Study Design

Enrollment
12 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tocilizumab plus Pembrolizumab (MK-3475)
    Tocilizumab 8 mg/kg (up to a maximum of 800 mg per dose) as an intravenous infusion over 60 minutes; single dose Pembrolizumab (MK3475) 200 mg as an intravenous infusion over 30 minutes; single dose. Patients who are showing no clinical improvement in respiratory function after 12 hours could receive an additional dose of tocilizumab at the same dose level of the first administration. Patients who are showing SpO2 ≤ 94% on room air could receive an additional administration of pembrolizumab (MK-3475) at the same recommended dose after 3 weeks from treatment initiation and/or an additional dose of tocilizumab after 4 weeks from treatment initiation at physician's discretion.
  • No Intervention: Continued Standard of Care
    Standard care per local written policies or guidelines comprises, as necessary and at physician's discretion, supplemental oxygen, noninvasive and invasive ventilation, antibiotic agents, vasopressor support, renal-replacement therapy, glucocorticoid, tocilizumab, virally targeted agents, chloroquine or hydroxychloroquine.

Primary Outcome Measure

Percentage of patients with normalization of SpO2 ≥96% on room air (measured without any respiratory support for at least 15 minutes [ Time Frame: through day 14 after study treatment initiation ]

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