COVID-19 trials registries data warehouse

https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=11037

Danielle Beaumont

crash19@lshtm.ac.uk

2020-05-12

Not recruiting

RCT

Randomized

Factorial

Open label

multi-center

Treatment

Adults age 40 years and older with suspected or confirmed acute COVID-19 infection (We use the following WHO criteria for a suspected case: A. A patient with acute respiratory illness (fever and at least one sign or symptom of respiratory disease, e.g., cough, shortness of breath), AND a history of travel to or residence in a location reporting community transmission of COVID-19 disease during the 14 days prior to symptom onset, OR B. A patient with any acute respiratory illness AND having been in contact with a confirmed or probable COVID-19 case in the last 14 days prior to symptom onset, OR C. A patient with severe acute respiratory illness (fever and at least one sign/symptom of respiratory disease, e.g., cough, shortness of breath, AND requiring hospitalization) AND in the absence of an alternative diagnosis that fully explains the clinical presentation.) requiring hospitalisation

Women known to be pregnant Patients hospitalised without symptoms of acute COVID-19 infection should not be recruited even if they test positive for COVID-19 Patients already receiving mechanical ventilation via an endotracheal tube Patients already receiving any of the trial treatments Patients with a definite indication or contraindication for any of the trial treatments. Patients who are very severely frail (completely dependent and approaching end of life who typically they could not recover even from a mild illness) or terminally ill should not be recruited.

8

London School of Hygiene and Tropical Medicine

40

100

Nigeria;Pakistan

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

10000

In-hopsital death. Cause of death will be described

| Declared number of arm (8.0) differs from found arms (9.0)

Phase 3

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