Covid19
Conditions
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.
Interventions
DRUGDoxycyclin
daily (100mg)
Sponsors
Dacima Consulting
Hedi Gharsallah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Double
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Tunisia
Outcome results
None listed