OD-doxy-PNV-COVID-19 Old Drug " DOXY " for Prevention of New Virus " COVID-19 "
Study Details
Study Description
Brief Summary
Given the urgency of having guidelines for the management of COVID-19 in the current epidemic context and the lack of specific pharmacological treatment, Military Health recommends the launch of a multicenter, randomized, double-blind, interventional clinical trial.
The aim of this study is to evaluate the efficacy of a combination of two treatments, low-dose doxcycline (100 mg/day) and Zinc (15 mg/day) (dietary supplement) in the primary prevention of COVID-19 infection in health care professionals in Tunisia compared to two control groups.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: DOXY ZINC Doxycycline daily dosing (100mg) Zinc daily dosing (15mg) |
Drug: Doxycyclin
daily (100mg)
|
Placebo Comparator: DOXY PLACEBO Doxycycline daily dosing (100mg) placebo of Zinc |
Drug: Doxycyclin
daily (100mg)
|
Placebo Comparator: PLACEBO placebo of Doxycycline daily dosing placebo of Zinc |
Drug: Doxycyclin
daily (100mg)
|
Outcome Measures
Primary Outcome Measures
- decreasing the number of cases infected with covid 19 [WEEK 6]
Determine if the use of doxyciciline low dose as preventive treatment decrease the number of cases infected with covid 19 in the active arm compared to the placebo arm. Participants for each randomized treatment arm as compared to placebo.
Secondary Outcome Measures
- Measurement of the emergence of clincal symptoms of COVID 19 [WEEK 6]
Comparison of the emergence of clinical symptoms or COVID-19 diagnosis in participants presenting asymptomatically at study entry but identified as seropositive by serology at entry between the randomized treatment arms and comparator arm.
- the seroprevalence of SARS- CoV 2 IgM/IgG positive samples at study entry and study conclusion in all participants receiving DOXY compared to those receiving placebo. [WEEK 6]
Comparison of the rate of SARS-CoV 2 infections as measured by IgM/IgG seroconversion in study participants receiving randomized DOXY versus placebo.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
No self-medication with study drugs or antivirals
-
Negative COVID19 diagnosis confirmed by PCR and negative Elisa antibody assay
-
No signs of COVID19
-
Having given consent for the study
Exclusion Criteria:
Participation in other clinical trials aimed at primary prevention of VIDOC infection19
-
Liver failure
-
Known allergy to the study product
-
Pregnancy or breastfeeding
-
Vitamin A and E treatment in progress
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Military Hospital of Tunis | Tunis | Montfleury | Tunisia | 1008 |
Sponsors and Collaborators
- Hedi Gharsallah
- Dacima Consulting
Investigators
- Study Chair: Batikh R Riadh, physican, Military hospital
- Study Director: Stambouli N nejla, phd, Military hospital
- Principal Investigator: Gharsallah H Hedi, physican, Military hospital
- Study Chair: Ferjani M Mustapha, physican, Direction de la Santé militaire
- Study Chair: Ben Moussa M mohamed, physican, Military hospital
- Study Chair: Youssfi MA Mohamed Al, physican, Military hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UR17DN05