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

Phase 3

Conditions: COVID-19
Covid-19
B34.2

Registration Number: LBCTR2020043495

Lead Sponsor: WHO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 1000

Inclusion Criteria

Eligibility: consenting adults (age =18) hospitalised with definite COVID-19, not already receiving any of the study drugs, without known allergy or contra-indications to any of them (in the view of the physician responsible for their care), and without anticipated transfer within 72 hours to a non-study hospital. Patients invited to join the study will be those who are admitted to a collaborating hospital; no wider recruitment efforts are expected.

Exclusion Criteria

Exclusion from study entry: Patients will not be randomised if, in the view of the randomising doctor, ANY of the AVAILABLE study drugs are contra-indicated (eg, because of patient characteristics, chronic liver or heart disease, or some concurrent medication).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ame: All-cause mortality, subdivided by severity of disease at the time of randomisation;Timepoints: At discharge or death;Measure: Discharge date or Cause of death

Secondary Outcome Measures

Name	Time	Method
ame: Assess any effects of these anti-viral treatments on hospital duration and receipt of ventilation or intensive care ;Timepoints: During Hospitalization while on treatment;Measure: Clinical improvement ;Name: Identify any serious adverse reactions;Timepoints: During Hospitalization while on treatment;Measure: Any serious unexpected adverse reaction that is life-threatening (e.g. anaphylaxis, Stevens-Johnson syndrome, aplastic anaemia, or anything comparably strange) must be reported within 24 hours;Name: Virological cure;Timepoints: After Treatment is finalized ;Measure: PCR negative twice within 48hours