Safety and Efficacy of Doxycycline and Rivaroxaban in COVID-19 (DOXYCOV)
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|ClinicalTrials.gov Identifier: NCT04715295|
Recruitment Status : Recruiting
First Posted : January 20, 2021
Last Update Posted : January 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Doxycycline Tablets Drug: Rivaroxaban 15Mg Tab Combination Product: Hydroxychloroquine and Azithromycin||Phase 4|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- Clinical [ Time Frame: Day 1 to 10 ]Change of Clinical stage of COVID-19
- Virological [ Time Frame: Day 1 to 10 ]Time to negativity of SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) on nasopharyngeal swab.
- Symptom remission [ Time Frame: Day 1 to 10 ]Time to remission of symptoms in days
- Hospitalisation [ Time Frame: Day 1 to 10 ]Need for hospitalisation due to worsening
- Mortality [ Time Frame: Day 1 to 10 ]All-cause mortality
- Biological variables [ Time Frame: Day 1 to Day 7 and Day 10 ]Change from baseline of WBC count
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
|Contact: Eugene Sobngwi, MD, PhDfirstname.lastname@example.org|
|Contact: Charles Kouanfack, MD, PhD|
|Yaounde Central Hospital||Recruiting|
|Yaounde, Centre, Cameroon|
|Principal Investigator:||Eugene Sobngwi||University of Yaounde 1|