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| Name | Class |
|---|---|
| Dacima Consulting | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DOXY ZINC | Experimental | Doxycycline daily dosing (100mg) Zinc daily dosing (15mg) |
|
| DOXY PLACEBO | Placebo Comparator | Doxycycline daily dosing (100mg) placebo of Zinc |
|
| PLACEBO | Placebo Comparator | placebo of Doxycycline daily dosing placebo of Zinc |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxycyclin | Drug | daily (100mg) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Participation in other clinical trials aimed at primary prevention of VIDOC infection19
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| Name | Affiliation | Role |
|---|---|---|
| Batikh R Riadh, physican | Military hospital | Study Chair |
| Stambouli N nejla, phd | Military hospital | Study Director |
| Gharsallah H Hedi, physican | Military hospital | Principal Investigator |
| 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 Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Military Hospital of Tunis | Tunis | Montfleury | 1008 | Tunisia |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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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.
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Double
| 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |