MK-4482 Ph 2/3 Study in Hospitalized Participants with COVID-19

INTERVENTION: Product Name: MK‐4482 Product Code: MK‐4482 Pharmaceutical Form: Capsule INN or Proposed INN: MK‐4482 CAS Number: 2349386‐89‐4 Current Sponsor code: MK‐4482 Other descriptive name: [(2R,3S,4R,5R)‐3,4‐dihydroxy‐5‐[4‐(hydroxyamino)‐2‐oxopyrimidin‐1‐yl]oxolan‐2‐yl]methyl 2‐methylpropanoate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use CONDITION: COVID‐19 ; MedDRA version: 23.0 Level: LLT Classification code 10084382 Term: Coronavirus disease 2019 System Organ Class: 100000004862 Therapeutic area: Diseases [C] ‐ Virus Diseases [C02] PRIMARY OUTCOME: Main Objective: 1. To evaluate the efficacy of MK‐4482 compared to placebo as assessed by the rate of sustained recovery from randomization through Day 29.; 2. To evaluate the safety and tolerability of MK‐4482 compared to placebo. Primary end point(s): 1. Time‐to‐sustained recovery; 2. Percentage of participants with an adverse event (AE); 3. Percentage of participants who discontinued study intervention due to an AE Secondary Objective: 1. To evaluate the efficacy of MK‐4482 compared to placebo as assessed by the percentage of participants who die through Day 29.; 2. To evaluate the efficacy of MK‐4482 compared to placebo as assessed by the odds of a more favorable response on selected ordinal outcome scales at Day 3, End of Treatment (EOT), Day 10, Day 15, and Day 29.; 3. To evaluate the efficacy of MK‐4482 compared to placebo as assessed by the odds of a more favorable response in the clinical risk of mortality category from the National Early Warning Score at EOT.; 4. To evaluate the efficacy of MK‐4482 compared to placebo as assessed by the odds of a more favorable response on the World Health Organization (WHO) 11‐point ordinal scale on Day 3, EOT, Day 10, Day 15, and Day 29.; ; Timepoint(s) of evaluation of this end point: 1. Up to Day 29; 2. Up to Month 7 ; 3. Up to Day 5 SECONDARY OUTCOME: Secondary end point(s): 1. Percentage of participants with all‐cause mortality; 2. Pulmonary score on a scale; 3. Pulmonary+ score on a scale; 4. National Early Warning Score on a scale; 5. WHO 11‐point outcomes score on a scale; ; ; Timepoint(s) of evaluation of this end point: 1. Up to Day 29; 2. Day 3, EOT, Day 10, Day 15, and Day 29; 3. Day 3, EOT, Day 10, Day 15, and Day 29; 4. EOT; 5. Day 3, EOT, Day 10, Day 15, and Day 29; ; INCLUSION CRITERIA: 1. Has documentation of PCR‐confirmed SARS‐CoV‐2 infection with sample collection = 10 days prior to randomization. 2. Had initial onset of signs/symptoms attributable to COVID‐19 for =10 days prior to randomization and =1 sign/symptom attributable to COVID‐19 present at randomization. 3. Requires medical care in the hospital for ongoing clinical manifestations of COVID‐19 (not just for public health or quarantine purposes). 4. Is willing and able to take oral medication. 5. Is male or female, =18 years of age, at the time of providing informed consent. 6. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: ‐ Refrain from donating sperm PLUS either: ‐ Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR

Epistemonikos ID: c00f2843d7afb9845319c99a6a9cb0f556cdca20
First added on: Oct 10, 2020