Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy of Doxycycline and Rivaroxaban in COVID-19 (DOXYCOV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04715295
Recruitment Status : Recruiting
First Posted : January 20, 2021
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
Sobngwi Eugene, Yaounde Central Hospital

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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Doxycycline Tablets Drug: Rivaroxaban 15Mg Tab Combination Product: Hydroxychloroquine and Azithromycin Phase 4

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 5, 2020
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : September 5, 2021


Arm Intervention/treatment
Experimental: Doxycyclin and Rivaroxaban
Oral Doxycyclin 200 mg daily for 7 days with or without Rivaroxaban
Drug: Doxycycline Tablets
Doxycycline 200 mg daily for 7 days
Other Name: Doxycycline

Drug: Rivaroxaban 15Mg Tab
Rivaroxaban 15 mg tablets daily from day 1 to day 10

Active Comparator: National Standard
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
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




Primary Outcome Measures :
  1. Clinical [ Time Frame: Day 1 to 10 ]
    Change of Clinical stage of COVID-19

  2. Virological [ Time Frame: Day 1 to 10 ]
    Time to negativity of SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) on nasopharyngeal swab.


Secondary Outcome Measures :
  1. Symptom remission [ Time Frame: Day 1 to 10 ]
    Time to remission of symptoms in days

  2. Hospitalisation [ Time Frame: Day 1 to 10 ]
    Need for hospitalisation due to worsening

  3. Mortality [ Time Frame: Day 1 to 10 ]
    All-cause mortality

  4. Biological variables [ Time Frame: Day 1 to Day 7 and Day 10 ]
    Change from baseline of WBC count



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04715295


Contacts
Layout table for location contacts
Contact: Eugene Sobngwi, MD, PhD +237675088750 sobngwieugene@yahoo.fr
Contact: Charles Kouanfack, MD, PhD

Locations
Layout table for location information
Cameroon
Yaounde Central Hospital Recruiting
Yaounde, Centre, Cameroon
Sponsors and Collaborators
Yaounde Central Hospital
Investigators
Layout table for investigator information
Principal Investigator: Eugene Sobngwi University of Yaounde 1
Layout table for additonal information
Responsible Party: Sobngwi Eugene, Medical Director, Yaounde Central Hospital
ClinicalTrials.gov Identifier: NCT04715295    
Other Study ID Numbers: CNO0032020
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared upon request and approval by the National COVID19 Scientific Board
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: one year after completion
Access Criteria: Data will be shared upon request and approval by the National COVID19 Scientific Board

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sobngwi Eugene, Yaounde Central Hospital:
COVID-19
Doxycycline
Rivaroxaban
Hydroxychloroquine
Additional relevant MeSH terms:
Layout table for MeSH terms
Azithromycin
Doxycycline
Hydroxychloroquine
Rivaroxaban
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Anticoagulants