NCT04715295.

Study name	Safety and efficacy of doxycycline and rivaroxaban in COVID‐19 (DOXYCOV)
Methods	Prospective, open‐label RCT
Participants	Number of participants: 200 Age: ≥ 18 years Gender: male or female Inclusion criteria COVID‐19 infection confirmed by SARS‐CoV‐2 RT‐PCR, as per protocol Able to start 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 contact person who can be contacted in case of emergency Exclusion criteria Blood pressure < 90/60 mmHg Respiratory rate ≥ 30/min Known cardiac condition Known G6PD deficiency Patients with < 45 kg body mass 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 randomisation showing QTc > 500 ms Ongoing treatment other than symptomatic History of retinopathy Absolute contraindication 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 with immunosuppressants at the time of randomisation Known pregnant women and breastfeeding women
Interventions	Intervention: doxycycline 200 mg daily for 7 days with or without rivaroxaban 15 mg tablets daily from day 1 to day 10 Control: 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 Comment: the trial plan is to use a factorial design to compare anticoagulant and control group. The co‐treatment seems to be balanced across arms.
Outcomes	Primary outcomes Clinical (time frame: day 1 to 10) Virological (time frame: day 1 to 10) 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)
Starting date	5 October 2020
Contact information	sobngwieugene@yahoo.fr
Notes