Status:
UNKNOWN
Safety and Efficacy of Doxycycline and Rivaroxaban in COVID-19
Lead Sponsor:
Yaounde Central Hospital
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
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 azithromy...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
October 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 5 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04715295
Start Date
October 5 2020
End Date
September 5 2021
Last Update
January 20 2021
Active Locations (1)
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1
Yaounde Central Hospital
Yaoundé, Centre Region, Cameroon