COVID-19 Prophylaxis South Africa (COVER HCW) (COVER)
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|ClinicalTrials.gov Identifier: NCT04561063|
Recruitment Status : Completed
First Posted : September 23, 2020
Last Update Posted : June 7, 2022
|Condition or disease||Intervention/treatment||Phase|
|Covid19 SARS-CoV Infection||Drug: Nitazoxanide Drug: Sofosbuvir/Daclatasvir||Phase 2|
This is a randomised, multi-center, open label, adaptive, exploratory trial to assess the efficacy of two different drug regimens in terms of preventing symptomatic COVID-19 disease in healthcare workers at high risk of exposure to SARS-CoV-2. The trial will compare two different experimental medication arms to the control arm comprising the use of standard personal protective equipment (PPE) with no additional pharmacological intervention.
Volunteers will be recruited from participating institutions and community healthcare workers (CHWs) that are responsible for collecting swabs for PCR detection of SARS-CoV-2. Up to 1950 (or 2130 pending funding) eligible participants will be randomised in a 1:1:1 ratio to one of the investigational arms.
Participants will be followed until 65 PCR and serology-confirmed, SARS-CoV-2 infections are identified in the control arm (or 165 in the entire study cohort). For each episode of PCR-confirmed COVID-19 disease, data on self-reported symptoms (modified Flu-PRO) and their duration, and an investigator-assessed severity score (WHO Ordinal Scale for Clinical Improvement) will be recorded. Data on self-reported symptoms and duration will also be collected for other all-cause acute respiratory illnesses. Safety and tolerability of each arm will be assessed through adverse event reporting. Participants who develop COVID-19 disease will have their IMP discontinued but will be followed up in the study until the completion of the trial, where possible. Multiple, discrete occurrences of COVID-19 disease could therefore be identified in a single participant.
Additional arms may be added, or existing ones substituted, should new potential agents be identified or other combinations for prophylaxis be proposed. A formal amendment will be documented should this be considered.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1950 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-center, Randomised, Open Label Study of Nitazoxanide (NTZ), or Sofosbuvir and Daclatasvir (SOF/DCV), Compared to no Pharmacological Intervention for the Prevention of COVID-19 Disease in Healthcare Workers and Inner City Inhabitants at High Risk of Exposure to SARS-CoV-2|
|Actual Study Start Date :||December 8, 2020|
|Actual Primary Completion Date :||February 28, 2022|
|Actual Study Completion Date :||February 28, 2022|
No Intervention: Arm A: No pharmacological intervention (PPE only)
Active Comparator: Arm B: Nitazoxanide (NTZ)
Nitozoxanide 1 tablet (500 mg) taken 12-hourly with food for the first week, followed by 2 tablets (1000 mg) taken 12-hourly with food thereafter. (Participants that fail to tolerated the 1000 mg 12-hourly dose may revert back to the lower dose.)
Active Comparator: Arm C: Sofosbuvir/daclatasvir (SOF/DCV).
Sofosbuvir/daclatasvir 400mg/60 mg sofosbuvir/daclatasvir fixed dose combination 1 tablet daily
- Number of SARS-CoV-2 infections [ Time Frame: 6 months ]Number of SARS-CoV-2 infection (COVID-19) confirmed by PCR and/or serology.
- Duration of symptoms [ Time Frame: 6 months ]Duration of symptoms for each symptomatic infection
- Maximum score on WHO Ordinal Scale [ Time Frame: 6 months ]Maximum score on WHO Ordinal Scale for Clinical Improvement for each symptomatic infection. Score of 0 being uninfected and a score of 8 being dead.
- Time to onset of SARS-CoV-2 infection [ Time Frame: 6 months ]Time to onset of SARS-CoV-2 infection (COVID-19) confirmed by PCR and/or serology
- Number of symptomatic SARS-CoV-2 infections [ Time Frame: 6 months ]Number of symptomatic SARS-CoV-2 infection (COVID-19) confirmed by PCR and/or serology
- Number of asymptomatic SARS-CoV-2 infections [ Time Frame: 6 months ]Number of asymptomatic • Asymptomatic SARS-CoV-2 infection suggested by serological outcome
- Peak score on modified Flu PRO [ Time Frame: 6 months ]Peak score on modified Flu-PRO during each symptomatic infection. 37-item questionairre assessing the severity of flu like symptoms one a scale of 0 - not at all to 5 - very much.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04561063
|Charlotte Maxeke Johannesburg Academic Hospital|
|Johannesburg, Gauteng, South Africa, 2196|
|Sunnyside Office Park|
|Johannesburg, Gauteng, South Africa|
|Principal Investigator:||Simiso Sokhela||Ezintsha|