Ministry of Health and Child Care/National Institute of Health Research/ MOHCC
Chiratidzo Ellen Ndhlovu
Associate Professor of Medicine
mascen@mweb.co.zw
+263772412701
Internal Medicine Unit, P O Box A 178, Avondale Harare
University of Zimbabwe
Chiratidzo Ellen Ndhlovu
Associate Professor of Medicine
mascen@mweb.co.zw
263772412701
Internal Medicine Unit, P O Box A 178, Avondale Harare
University of Zimbabwe
Multi-country WHO Sponsored SOLIDARITY PLUS Trial
World Health Organisation
Will only enrol hospitalized patients with confirmed COVID-19 infection
Artesunate
Unknown
adults (age ≥18 years, which allows own consent or by guardian),
recently hospitalised (or already in hospital) with laboratory-confirmed COVID-19,
not expected to be transferred within 72 hours,
with, in the view of their doctors, no contra-indication to any potentially relevant study drug.
Patients unable to give consent and without a surrogate will not be included in the study.
Those with known hypersensitivity to the active substance or to any of the excipients will not receive the medicine.
To determine in-hospital mortality from any cause among all randomised patients.
To determine time of initiation of ventilation, and duration of hospital stay among the randomized patients.
To assess reported serious adverse events (SAEs) and suspected and unsuspected serious adverse reaction (SUSARs) related to the treatment.
9.0 DESIGN OF THE TRIAL
Opened
If controlled
Yes
Yes
adaptive pragmatic platform in a pandemic setting with 4 arms including Standard of Care arm
Standard of care as applied in each country
Yes
Yes
Whatever products are used in the standard of care which as a minimum in Zimbabwe are oxygen therapy plus steroids
Yes
10
No specific number to be enrolled. WHO will be conducting interim analyses and will tell us when we stop recruiting participants once the primary objective has been answered.
986
Trail started in other countries in August 2021 and we are supposed to be funded until December 2022. Trail may be stopped whenever the global numbers are enough to answer the primary objective ie. reduction in mortality with use of these medicines or if lack of utility of their use is noted.