OD-doxy-PNV-COVID-19 Old Drug  DOXY  for Prevention of New Virus  COVID-19 

Study Overview
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Brief Summary
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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.

Official Title
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Covid-19 Infection Prophylaxis With Low Dose of Doxycycline and Zinc in Health Care Workers

Conditions
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Covid19

Intervention / Treatment
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* Drug: Doxycyclin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The participants who meeting study entry criteria will be randomized in a 1:1 blinded comparison of daily low dose DOXY versus oral placebo for 6 weeks.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DOXY ZINC<br>Doxycycline daily dosing (100mg) Zinc daily dosing (15mg) | Drug: Doxycyclin<br>* daily (100mg)<br>|
| Placebo Comparator: DOXY PLACEBO<br>Doxycycline daily dosing (100mg) placebo of Zinc | Drug: Doxycyclin<br>* daily (100mg)<br>|
| Placebo Comparator: PLACEBO<br>placebo of Doxycycline daily dosing placebo of Zinc | Drug: Doxycyclin<br>* daily (100mg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decreasing the number of cases infected with covid 19 | 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. | WEEK 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the emergence of clincal symptoms of COVID 19 | 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. | WEEK 6 | 
| 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. | Comparison of the rate of SARS-CoV 2 infections as measured by IgM/IgG seroconversion in study participants receiving randomized DOXY versus placebo. | WEEK 6 |