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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04584567
• Other study ID #: UR17DN05
• Status: Completed
• Phase: Phase 3
• Start date: November 20, 2020
• Est. completion date: November 1, 2021

Study information

• Verified date: November 2021
• Source: General Administration of Military Health, Tunisia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: November 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• Doxycyclin
daily (100mg)

Locations

Country	Name	City	State
Tunisia	Military Hospital of Tunis	Tunis	Montfleury

Sponsors (2)

Lead Sponsor	Collaborator
Hedi Gharsallah	Dacima Consulting

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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