Status:
TERMINATED
Catalysing the Containment of COVID-19
Lead Sponsor:
University of Cape Town
Collaborating Sponsors:
Medical Research Council, South Africa
Aurum Institute
Conditions:
COVID-19
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
PHASE3
Brief Summary
COVID-19 due to SARS-CoV-2 infection is a rapidly escalating global pandemic for which there is no proven effective treatment. COVID-19 is multi-dimensional disease caused by viral cytopathic effects ...
Detailed Description
COVID-19 that is caused by SARS-CoV-2 infection is a rapidly escalating global pandemic(9). The pandemic is on an upward and escalating trajectory in most countries though some countries like China ha...
Eligibility Criteria
Inclusion
- Adults \>18 years of age.
- Confirmed COVID-19 on antigen testing\* and/or RT-PCR using NP or OP swabs (or sputum or another sample e.g. stool).
- Only SAHPRA approved antigen tests will be used to identify COVID-19. A positive antigen detection test will be valid provided that at least one serial PCR test is positive.
- Presenting within 6 days of symptom onset.
- Not requiring immediate hospitalisation.
- Patients with non-severe not requiring admission i.e. mild disease (respiratory rate \<25/min), pulse rate \<120 beats/min, oxygen saturation of ≥93% at sea level sites and \>91% at high altitude sites)
- Enhanced risk and/or HIV-infected
Exclusion
- Refusal or unable to sign informed consent.
- Patient who declines or will be unable to comply with follow up visits by study staff.
- Patients with advanced organ dysfunction/co-morbid conditions that in the opinion of the study doctor would compromise the patient's well-being.
- Patients who have had symptoms for \> 6 days (as at the day of recruitment).
- Patients who refuse HIV-testing.
- Patients using warfarin (Appendix A in the protocol)
- Patients with a body weight of less than 40kg.
- Women of child-bearing age (18-50 years) with a positive urine pregnancy test at randomisation.
- Female patients who are currently breastfeeding.
- Patients without HIV infection or at least one enhanced risk characteristic
Key Trial Info
Start Date :
August 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2022
Estimated Enrollment :
322 Patients enrolled
Trial Details
Trial ID
NCT04523090
Start Date
August 27 2020
End Date
August 12 2022
Last Update
August 16 2022
Active Locations (4)
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1
The Aurum Institute
Tembisa, Gauteng, South Africa
2
University of KwaZulu-Natal
Durban, KwaZulu-Natal, South Africa
3
Perinatal HIV Research Unit
Klerksdorp, North West, South Africa
4
University of Cape Town
Cape Town, Western Cape, South Africa