Safety and Efficacy of Doxycycline and Rivaroxaban in COVID-19

• Status: Recruiting
• Trial end date: 2021-09-05
• Target enrollment: 0
• Participant gender: All

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, 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yaounde Central Hospital
• Treatments: Azithromycin; Doxycycline; Hydroxychloroquine; Rivaroxaban

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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