Covid19Phase 3NCT04584567
OD-doxy-PNV-COVID-19 Old Drug " DOXY " for Prevention of New Virus " COVID-19 "
A Phase 3 study testing Doxycyclin in people with Covid19, run by Hedi Gharsallah at 1 site in Tunisia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Covid19
- What is being tested?
- Doxycyclin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 194 participants
- Where
- 1 siteTunisia
- Study dates
- 20 Nov 2020to 1 Nov 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Covid-19 Infection Prophylaxis With Low Dose of Doxycycline and Zinc in Health Care Workers
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
- Being tested
- Doxycyclin
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclinDrug
daily (100mg)
| Study group | Role | What they receive |
|---|---|---|
| DOXY ZINC | Experimental | Doxycycline daily dosing (100mg) Zinc daily dosing (15mg) Receives: Drug: Doxycyclin |
| DOXY PLACEBO | Placebo comparator | Doxycycline daily dosing (100mg) placebo of Zinc Receives: Drug: Doxycyclin |
| PLACEBO | Placebo comparator | placebo of Doxycycline daily dosing placebo of Zinc Receives: Drug: Doxycyclin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: WEEK 6
Secondary outcomes (2)
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.
Measured: 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.
Measured: WEEK 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start20 Nov 2020
- Primary completion1 Feb 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hedi Gharsallah
- Sponsor type
- Research network
- Collaborators
- Dacima Consulting
- Responsible party
- Sponsor-investigator, Hedi Gharsallah, General Administration of Military Health, Tunisia
- Investigators
- Batikh R Riadh, physican, Study chair, Military hospitalStambouli N nejla, phd, Study director, Military hospitalGharsallah H Hedi, physican, Principal investigator, Military hospitalFerjani M Mustapha, physican, Study chair, Direction de la Santé militaireBen Moussa M mohamed, physican, Study chair, Military hospitalYoussfi MA Mohamed Al, physican, Study chair, Military hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584567
- Sponsor's protocol ID
- UR17DN05
- Status last verified
- Nov 2021
- First submitted
- 6 Oct 2020
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Covid-19 Infection Prophylaxis With Low Dose of Doxycycline and Zinc in Health Care Workers
- ClinicalTrials.gov ID
- NCT04584567
- Acronym / sponsor ID
- UR17DN05
- Conditions
- Covid19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Hedi GharsallahResearch network
- Collaborators
- Dacima Consulting
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| DOXY ZINC | Experimental | Drug: DoxycyclinDoxycycline daily dosing (100mg) Zinc daily dosing (15mg) |
| DOXY PLACEBO | Placebo comparator | Drug: DoxycyclinDoxycycline daily dosing (100mg) placebo of Zinc |
| PLACEBO | Placebo comparator | Drug: Doxycyclinplacebo of Doxycycline daily dosing placebo of Zinc |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doxycyclindaily (100mg) | Drug | DOXY PLACEBO, DOXY ZINC, PLACEBO |
Primary outcome
decreasing the number of cases infected with covid 19
Time frame: 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.
2 secondary outcomes
Measurement of the emergence of clincal symptoms of COVID 19
Time frame: 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.
Time frame: WEEK 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Batikh R Riadh, physican study chair
Military hospital
Stambouli N nejla, phd study director
Military hospital
Gharsallah H Hedi, physican principal investigator
Military hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Doxycyclin in people with Covid19, run by Hedi Gharsallah at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
decreasing the number of cases infected with covid 19 (time frame: WEEK 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.