Safety and Efficacy of Enoxaparin and Hydroxychloroquine in COVID-19

COVID-19 Pandemic Clinical Trial

Official title:

Evaluation of Safety and Efficacy of Monotherapy Versus Polytherapy of Enoxaparin and Hydroxychloroquine for the Treatment of Covid-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05311813
• Other study ID #: REC-H-PhBSU-21013
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: April 2022
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this randomized controlled study, two hundred patients with positive PCR and laboratory confirmed COVID-19 will be classified randomly into four groups. The first group is the control group and will be given the conventional treatment of covid-19 only. The second group will be given enoxaparin plus the conventional treatment of Covid-19. The third group will be given hydroxychloroquine (HCQ 400 mg/day) for five days plus the conventional treatment of covid-19. The last group will be given combined therapy of HCQ 400 mg/day and enoxaparin plus the conventional therapy of covid-19

The efficacy will be assessed by the time of undetectable viral RNA, duration of treatment and length of hospital stay. The safety will be assessed by measuring the severity of side effects by following up the patients after treatment.

Description:

Although numerous therapeutic agents for COVID-19 are under investigation, an effective therapy remains a challenge among researchers. To date, hydroxychloroquine has been widely used for covid-19 treatment, despite that its efficacy and safety need further investigations. Coagulopathies are major complications of covid-19 infection, hence prophylactic anticoagulation has been recommended in all hospitalized patients. This study aims to assess the efficacy and safety of Enoxaparin and hydroxychloroquine used separately or combined and added to standard care versus standard care alone in Covid-19 infected patients. An observational study including two hundred patients (98 males, 102 females) with laboratory confirmed covid-19 infection was conducted. Patients admitted to hospital were randomly allocated into four equal treatment groups. The first group received standard Covid-19 therapy, second group received enoxaparin 40mg/day SC for 14 days plus standard Covid-19 therapy, third group received 400 mg/day HCQ for five days plus standard Covid-19 therapy. The fourth group received a combination of 400 mg/day HCQ and enoxaparin plus standard Covid-19 therapy. The clinical disease course progression was evaluated by duration to a negative PCR, length of hospital or ICU stay, and mortality rate. The safety of treatments was evaluated by measuring liver biochemistries (ALT, AST), random blood glucose levels and adverse effects during the 28 days of treatment. Patients on Enoxaparin plus standard Covid-19 therapy significantly showed a decrease in length of hospital stay, ICU admission and mortality compared to all other treatments. However, the duration to both negative PCR and clinical improvement did not find any significance. These findings suggest that enoxaparin treatment was safe, effective, and well tolerated and has a role in decreasing the progression of the disease and its complications while HCQ did not discover any evidence of extra therapeutic benefits over other treatments.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 30, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Laboratory confirmed COVID-19 infection by PCR test within 7 days prior to admission or during admission to hospital, CT or radiographic findings of pneumonia. Clinically suspected infection by symptoms like loss of smell and taste. No medical history that may interfere with treatment or with this clinical trial.

Exclusion Criteria:

• Patient who had allergy or contraindication to HCQ, pregnant and lactating females, and patients with immune diseases, cardiac problem, had history of acute kidney injury or who received multiple cycles of anticoagulants were excluded from the study. Written informed consent was obtained from each participant. All study risks and benefits were thoroughly explained to patients' prior participation

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic

Intervention

Drug:
• Enoxaparin, Hydroxychloroquine
To compare efficiency and safety of Enoxaparin and Hydroxychloroquine as monotherapy versus Polytherapy

Locations

Country	Name	City	State
Egypt	Beni-Suef University teaching Hospital	Bani Suwayf	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of efficacy	The hospital stay of COVID-19 patients	6 monthes
Secondary	Assessment of Safety	Mortality of COVID-19 patients	6 monthes