Multi-site, randomized, double-blind, multi-arm historical control, comparative trial of the safety and efficacy of hydroxychloroquine and the combination of hydroxychloroquine and famotidine for treatment of moderate to severe COVID-19 disease in hospital

Award Notice Posted

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Solicitation number
75A50120C00078
Agency
Awarded
to Alchem Laboratories Corporation
Set-aside
No set-aside

Opportunity facts

Contract number
75A50120C00078 Federal contract award

Notice details come from SAM.gov. Updated .

About this opportunity

This Award Notice from the Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response provides $20,747,018 to ALCHEM LABORATORIES CORP to rapidly implement a multi-site, randomized, double-blind study comparing the safety and efficacy of hydroxychloroquine alone and in combination with famotidine for the treatment of moderate to severe COVID-19 in hospitalized adults over an unspecified period. The study will evaluate standard of care combined with hydroxychloroquine or the combination of hydroxychloroquine and high-dose intravenous famotidine against standard of care alone.

Notice text

The objective of this contract is rapidly implement a multi-site, randomized, double-blind, multi-arm historical control, comparative trial of the safety and efficacy of Hydroxychloroquine and the combination of Hydroxychloroquine and Famotidine for the treatment of moderate to severe COVID-19 disease in hospitalized adults.  The study will help evaluate the clinical efficacy of COVID-19 treatments consisting of standard of care (SOC) combined with pharmaceutical antiviral management using Hydroxychloroquine or SOC or SOL combine with Hydroxychloroquine and high-dose intravenous famotidine in hospitalized patients meeting nucleic acid diagnostic and radiologic criteria for COVID-19 disease. Additional dose-ranging or therapeutic strategies including additional therapeutic compounds, as well as clinical sample testing, to improve COVID-19 treatments are also proposed.

Awarded contract 75A50120C00078 to ALCHEM LABORATORIES CORP for 20747018.00 on 2020-04-14.

Notice history

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