COVID-19Phase 4DOXYCOVNCT04715295
Safety and Efficacy of Doxycycline and Rivaroxaban in COVID-19
A Phase 4 study testing Doxycycline Tablets, Rivaroxaban 15Mg Tab and Hydroxychloroquine and Azithromycin in people with COVID-19, run by Yaounde Central Hospital at 1 site in Cameroon.
Trial summary
This is an exploratory study to evaluate the efficacy of Doxycycline (200mg on D1 to D7) and Rivaroxaban (15 mg daily on D1 to D7) versus the combination of Hydroxychloroquine (400 mg on D1 to D7) and Azithromycin (500 mg on D1 and 250mg on D2 to D5) as per national standard to treat ambulatory mild COVID-19 patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Doxycycline Tablets, Rivaroxaban 15Mg Tab and Hydroxychloroquine and Azithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCameroon
- Study dates
- 5 Oct 2020to 5 Sep 2021
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COVID-19 infection confirmed by SARS-Cov2 - RT PCR - as per protocol
- Able to start the treatment within 24 hours from time of diagnosis
- Patient with mild symptoms as defined by WHO, with PaO2 > 93%
- Signed written consent of the patient
- Accepts and has the ability to be reached by phone during the study duration, plus a designated a contact person who can be contacted in case of emergency
Who cannot join
- Blood pressure < 90/60mm Hg
- Respiratory rate ≥ 30/min
- Known cardiac condition
- Known G6PD deficiency
- Patients with < 45kg
- eGFR < 30 ml/min or ALT ≥ 3N or body temperature ≥ 38°C or any life-threatening comorbidity
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- Any reason that makes it impossible to monitor the patient during the study period
- Baseline ECG prior to randomization showing QTc > 500 ms
- Ongoing treatment other than symptomatic
- history of retinopathy
- Absolute contra-indication to treatment with hydroxychloroquine (known hypersensitivity, concomitant treatment at risk of torsades de pointes)
- Contraindication to any study medication including allergy
- Ongoing treatment with high dose systemic chronic corticosteroid (> 40 mg)
- Patients treated by immunosuppressants treatment at the time of randomization
- Known Pregnant women and breastfeeding women
Trial locations and contacts
1 site in 1 country.
Charles Kouanfack, MD, PhD contact
Cameroon1 site, 1 recruiting
- Recruiting
Yaounde Central Hospital
Yaoundé, Centre Region
About this study
Official title: Open-label, Randomized Trial of the Safety and Efficacy of Doxycycline and Rivaroxaban Therapy Versus National Standard Therapy in Ambulatory Patients With Mild Symptomatic COVID-19
This is an exploratory study to evaluate the efficacy of Doxycycline (200mg on D1 to D7) and Rivaroxaban (15 mg daily on D1 to D7) versus the combination of Hydroxychloroquine (400 mg on D1 to D7) and Azithromycin (500 mg on D1 and 250mg on D2 to D5) as per national standard to treat ambulatory mild COVID-19 patients, with the aim to achieve early negativity of RT-PCR of SARS-CoV-2 from nasopharyngeal swab, and early clinical improvement and prevention of severe disease.
Read the detailed description
This is an exploratory study to evaluate the efficacy of Doxycycline (200mg on D1 to D7) and Rivaroxaban (15 mg on D1 to D7) versus combination of hydroxychloroquine (400 mg on D1 to D7) and azithromycin (500 mg on D1 and 250mg on D2 to D5) to treat ambulatory patients with mild COVID-19.
We aim to demonstrate early improvement of a clinical core set of outcomes and prevention of clinical worsening, and early negativity of SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) among ambulatory patients with mild COVID-19 by treating them with Doxycycline and Rivaroxaban compared to patients who receive Hydroxychloroquine and Azithromycin as per National standard therapy of COVid-19.
Ambulatory patients with mild symptoms and with confirmed diagnosis of COVID-19 will receive the treatment.
The primary objective of the study is to evaluate the Safety and Efficacy of Doxycycline and Rivaroxaban versus National standard therapy of mild COVid-19.
The primary endpoint is failure (i.e severe evolution) measured as PaO2 < 92% within 10 days after initiation of treatment.
The secondary objectives of the study are to evaluate
- Safety of the different investigational therapies up to D10 days of follow-up per arm,
- Hospitalisation due to Covid 19 infection rate per arm,
- Time to hospitalisation due to Covid 19 infection,
- Cure rate by treatment arm and Death rate,
- Worsening as assessed by the need for additional concomitant medication,
- Efficacy in sub-groups of patients (with pre-existing conditions/co-morbidities and by age group).
- Conditions
- COVID-19
- Being tested
- Doxycycline Tablets, Rivaroxaban 15Mg Tab, Hydroxychloroquine and Azithromycin
- Keywords
- COVID-19, Doxycycline, Rivaroxaban, Hydroxychloroquine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxycycline TabletsDrug
Also called Doxycycline
Doxycycline 200 mg daily for 7 days
Rivaroxaban 15Mg TabDrug
Rivaroxaban 15 mg tablets daily from day 1 to day 10
Hydroxychloroquine and AzithromycinCombination product
Hydroxychloroquine 400mg daily from day 1 to day 5 in combination with Azithromycin 500mg on day 1 and 250 mg daily from day 2 to day 5
| Study group | Role | What they receive |
|---|---|---|
| Doxycyclin and Rivaroxaban | Experimental | Oral Doxycyclin 200 mg daily for 7 days with or without Rivaroxaban Receives: Drug: Doxycycline Tablets; Drug: Rivaroxaban 15Mg Tab |
| National Standard | Active comparator | Hydroxychloroquine 400 mg daily for 5 days in combination with Azithromycin 500 mg on day 1 and 250 mg daily from day 2 through day 5 Receives: Combination Product: Hydroxychloroquine and Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical
Change of Clinical stage of COVID-19
Measured: Day 1 to 10
Virological
Time to negativity of SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) on nasopharyngeal swab.
Measured: Day 1 to 10
Secondary outcomes (4)
Symptom remission
Time to remission of symptoms in days
Measured: Day 1 to 10
Hospitalisation
Need for hospitalisation due to worsening
Measured: Day 1 to 10
Mortality
All-cause mortality
Measured: Day 1 to 10
Biological variables
Change from baseline of WBC count
Measured: Day 1 to Day 7 and Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start5 Oct 2020
- Primary completion30 May 2021 (estimated)
- Study completion5 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yaounde Central Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sobngwi Eugene, Yaounde Central Hospital
- Investigators
- Eugene Sobngwi, Principal investigator, University of Yaounde 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715295
- Sponsor's protocol ID
- CNO0032020
- Acronym
- DOXYCOV
- Status last verified
- Jan 2021
- First submitted
- 2 Oct 2020
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon request and approval by the National COVID19 Scientific Board
Publications
Santos BC, Flumignan RL, Civile VT, Atallah AN, Nakano LC. Prophylactic anticoagulants for non-hospitalised people with COVID-19. Cochrane Database Syst Rev. 2023 Aug 16;8(8):CD015102. doi: 10.1002/14651858.CD015102.pub2.
PubMed 37591523
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Randomized Trial of the Safety and Efficacy of Doxycycline and Rivaroxaban Therapy Versus National Standard Therapy in Ambulatory Patients With Mild Symptomatic COVID-19
- ClinicalTrials.gov ID
- NCT04715295
- Acronym / sponsor ID
- DOXYCOV / CNO0032020
- Conditions
- COVID-19
- Keywords
- COVID-19, Doxycycline, Rivaroxaban, Hydroxychloroquine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yaounde Central HospitalOther government
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 30 May 2021 (estimated)
- Study completion
- 5 Sep 2021 (estimated)
- First posted
- 20 Jan 2021 (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.
This is an exploratory study to evaluate the efficacy of Doxycycline (200mg on D1 to D7) and Rivaroxaban (15 mg daily on D1 to D7) versus the combination of Hydroxychloroquine (400 mg on D1 to D7) and Azithromycin (500 mg on D1 and 250mg on D2 to D5) as per national standard to treat ambulatory mild COVID-19 patients, with the aim to achieve early negativity of RT-PCR of SARS-CoV-2 from nasopharyngeal swab, and early clinical improvement and prevention of severe disease.
Detailed description
This is an exploratory study to evaluate the efficacy of Doxycycline (200mg on D1 to D7) and Rivaroxaban (15 mg on D1 to D7) versus combination of hydroxychloroquine (400 mg on D1 to D7) and azithromycin (500 mg on D1 and 250mg on D2 to D5) to treat ambulatory patients with mild COVID-19.
We aim to demonstrate early improvement of a clinical core set of outcomes and prevention of clinical worsening, and early negativity of SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) among ambulatory patients with mild COVID-19 by treating them with Doxycycline and Rivaroxaban compared to patients who receive Hydroxychloroquine and Azithromycin as per National standard therapy of COVid-19.
Ambulatory patients with mild symptoms and with confirmed diagnosis of COVID-19 will receive the treatment.
The primary objective of the study is to evaluate the Safety and Efficacy of Doxycycline and Rivaroxaban versus National standard therapy of mild COVid-19.
The primary endpoint is failure (i.e severe evolution) measured as PaO2 < 92% within 10 days after initiation of treatment.
The secondary objectives of the study are to evaluate
- Safety of the different investigational therapies up to D10 days of follow-up per arm,
- Hospitalisation due to Covid 19 infection rate per arm,
- Time to hospitalisation due to Covid 19 infection,
- Cure rate by treatment arm and Death rate,
- Worsening as assessed by the need for additional concomitant medication,
- Efficacy in sub-groups of patients (with pre-existing conditions/co-morbidities and by age group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxycyclin and Rivaroxaban | Experimental | Drug: Doxycycline Tablets, Drug: Rivaroxaban 15Mg TabOral Doxycyclin 200 mg daily for 7 days with or without Rivaroxaban |
| National Standard | Active comparator | Combination Product: Hydroxychloroquine and AzithromycinHydroxychloroquine 400 mg daily for 5 days in combination with Azithromycin 500 mg on day 1 and 250 mg daily from day 2 through day 5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- COVID-19 infection confirmed by SARS-Cov2 - RT PCR - as per protocol
- Able to start the treatment within 24 hours from time of diagnosis
- Patient with mild symptoms as defined by WHO, with PaO2 > 93%
- Signed written consent of the patient
- Accepts and has the ability to be reached by phone during the study duration, plus a designated a contact person who can be contacted in case of emergency
Key exclusion criteria (15 listed)
- Blood pressure < 90/60mm Hg
- Respiratory rate ≥ 30/min
- Known cardiac condition
- Known G6PD deficiency
- Patients with < 45kg
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 |
|---|---|---|
| Doxycycline TabletsAlso: DoxycyclineDoxycycline 200 mg daily for 7 days | Drug | Doxycyclin and Rivaroxaban |
| Rivaroxaban 15Mg TabRivaroxaban 15 mg tablets daily from day 1 to day 10 | Drug | Doxycyclin and Rivaroxaban |
| Hydroxychloroquine and AzithromycinHydroxychloroquine 400mg daily from day 1 to day 5 in combination with Azithromycin 500mg on day 1 and 250 mg daily from day 2 to day 5 | Combination product | National Standard |
Primary outcome
Clinical
Time frame: Day 1 to 10
Change of Clinical stage of COVID-19
Virological
Time frame: Day 1 to 10
Time to negativity of SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) on nasopharyngeal swab.
4 secondary outcomes
Symptom remission
Time frame: Day 1 to 10
Hospitalisation
Time frame: Day 1 to 10
Mortality
Time frame: Day 1 to 10
Biological variables
Time frame: Day 1 to Day 7 and Day 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Derived from this study: PubMed 37591523Santos BC, Flumignan RL, Civile VT, Atallah AN, Nakano LC. Prophylactic anticoagulants for non-hospitalised people with COVID-19. Cochrane Database Syst Rev. 2023 Aug 16;8(8):CD015102. doi: 10.1002/14651858.CD015102.pub2.
- Individual participant dataSharing planned: Yes. Data will be shared upon request and approval by the National COVID19 Scientific Board
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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.
Charles Kouanfack, MD, PhD contact
Eugene Sobngwi principal investigator
University of Yaounde 1
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Doxycycline Tablets, Rivaroxaban 15Mg Tab and Hydroxychloroquine and Azithromycin in people with COVID-19, run by Yaounde Central Hospital at 1 site in Cameroon.
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 5 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 20 Jan 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 Cameroon. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eugene Sobngwi, MD, PhD (+237675088750, sobngwieugene@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical (time frame: Day 1 to 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04715295, which also lists 1 linked publication.
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 20 Jan 2021.