Safety and Efficacy of Doxycycline and Rivaroxaban in COVID-19

NCT04715295 | Unknown Phase 4 DMC

• 1 other identifier: CNO0032020
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 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.

Conditions

COVID-19

Keywords

COVID-19; Doxycycline; Rivaroxaban; Hydroxychloroquine

Outcome Measures

Primary Outcomes (2)

• Clinical

  Change of Clinical stage of COVID-19

  Day 1 to 10

• Virological

  Time to negativity of SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) on nasopharyngeal swab.

  Day 1 to 10

Secondary Outcomes (4)

• Symptom remission

  Day 1 to 10

• Hospitalisation

  Day 1 to 10

• Mortality

  Day 1 to 10

• Biological variables

  Day 1 to Day 7 and Day 10

Study Arms (2)

Doxycyclin and Rivaroxaban

EXPERIMENTAL

Oral Doxycyclin 200 mg daily for 7 days with or without Rivaroxaban

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

Combination Product: Hydroxychloroquine and Azithromycin

Interventions

Doxycycline Tablets DRUG

Doxycycline 200 mg daily for 7 days

Also known as: Doxycycline

Doxycyclin and Rivaroxaban

Rivaroxaban 15Mg Tab DRUG

Rivaroxaban 15 mg tablets daily from day 1 to day 10

Doxycyclin and Rivaroxaban

Hydroxychloroquine and Azithromycin COMBINATION_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

National Standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yaounde Central Hospital: lead

Study Sites (1)

Yaounde Central Hospital

Yaoundé, Centre Region, Cameroon

RECRUITING

Related Publications (1)

• 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.

  PMID: 37591523 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Doxycycline; Rivaroxaban; Hydroxychloroquine; Azithromycin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Thiophenes; Sulfur Compounds; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• Eugene Sobngwi

  University of Yaounde 1

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eugene Sobngwi, MD, PhD

CONTACT

+237675088750; sobngwieugene@yahoo.fr

Charles Kouanfack, MD, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: January 20, 2021
• Study Start: October 5, 2020
• Primary Completion: May 30, 2021
• Study Completion: September 5, 2021
• Last Updated: January 20, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: one year after completion
• Access Criteria: Data will be shared upon request and approval by the National COVID19 Scientific Board

Locations

CA (1)