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

NCT04584567 | Completed Phase 3 DMC

• 1 other identifier: UR17DN05
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Measurement of the emergence of clincal symptoms of COVID 19

  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.

  WEEK 6

Study Arms (3)

DOXY ZINC

EXPERIMENTAL

Doxycycline daily dosing (100mg) Zinc daily dosing (15mg)

Drug: Doxycyclin

DOXY PLACEBO

PLACEBO COMPARATOR

Doxycycline daily dosing (100mg) placebo of Zinc

Drug: Doxycyclin

PLACEBO

PLACEBO COMPARATOR

placebo of Doxycycline daily dosing placebo of Zinc

Drug: Doxycyclin

Interventions

Doxycyclin DRUG

daily (100mg)

DOXY PLACEBO; DOXY ZINC; PLACEBO

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hedi Gharsallah: lead
• Dacima Consulting: collaborator

Study Sites (1)

Military Hospital of Tunis

Tunis, Montfleury, 1008, Tunisia

Location

MeSH Terms

Conditions

COVID-19

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 14, 2020
• Study Start: November 20, 2020
• Primary Completion: February 1, 2021
• Study Completion: November 1, 2021
• Last Updated: November 19, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)