An international randomised trial of additional treatments for COVID-19 in hospitalised patients who are all receiving the local standard of care

INTERVENTION: Product Name: Remdesivir Pharmaceutical Form: Lyophilisate for solution for infusion INN or Proposed INN: REMDESIVIR Current Sponsor code: REMDESIVIR Other descriptive name: REMDESIVIR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Trade Name: Chloroquine Pharmaceutical Form: Tablet INN or Proposed INN: Chloroquine CAS Number: 54‐05‐7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250‐ Trade Name: HYDROXYCHLOROQUINE SULFATE Pharmaceutical Form: INN or Proposed INN: HYDROXYCHLOROQUINE SULFATE CAS Number: 747‐36‐4 Current Sponsor code: HYDROXYCHLOROQUINE SULFATE Other descriptive name: HYDROXYCHLOROQUINE SULFATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ Trade Name: Lopinavir/Ritonavir Pharmaceutical Form: INN or Proposed INN: LOPINAVIR CAS Number: 192725‐17‐0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ Trade Name: Interferón b 1A Pharmaceutical Form: INN or Proposed INN: Interferon beta‐1a CAS Number: 220581‐49‐7 Current Sponsor code: Interferon beta‐1a Other descriptive name: Interferon beta‐1a Concentration unit: g gram(s) Concentration type: equal Concentration number: 152‐ CONDITION: COVID‐19 Therapeutic area: Diseases [C] ‐ Virus Diseases [C02] PRIMARY OUTCOME: Main Objective: The aim of this core protocol is to compare the effects on major outcomes in hospital of the local standard of care alone versus the local standard of care plus one of four alternative anti‐viral agents. ; ; The primary objective of this large international randomised trial is to provide reliable estimates on any effects of these anti‐viral treatments on in‐hospital mortality in moderate and in severe COVID Primary end point(s): The primary outcome is all‐cause mortality, subdivided by severity of disease at the time of randomisation. Secondary Objective: The secondary objectives are to assess any effects of these anti‐viral treatments on hospital duration and receipt of ventilation or intensive care, and to identify any serious adverse reactions. Timepoint(s) of evaluation of this end point: At discharge or death. SECONDARY OUTCOME: Secondary end point(s): The major secondary outcomes are duration of hospital stay and time to first receiving ventilation or intensive care. Timepoint(s) of evaluation of this end point: At discharge or death. INCLUSION CRITERIA: consenting adults (age =18) hospitalised with definite COVID‐19, not already receiving any of the study drugs Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2000