Safety and Efficacy of Enoxaparin and Hydroxychloroquine in COVID-19

NCT05311813 | Completed DMC

• 1 other identifier: REC-H-PhBSU-21013
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19 Pandemic

Keywords

COVID-19 infection; Enoxaparin; Hydroxychloroquine; ICU stay

Outcome Measures

Primary Outcomes (1)

• Assessment of efficacy

  The hospital stay of COVID-19 patients

  6 monthes

Secondary Outcomes (1)

• Assessment of Safety

  6 monthes

Study Arms (4)

Control group

PLACEBO COMPARATOR

The control group including 50 patients (n=50) receiving the conventional therapy of Covid-19 adopted by the Egyptian ministry of health for 15 days.

Drug: Enoxaparin, Hydroxychloroquine

Enaxoprin group

ACTIVE COMPARATOR

The enoxaparin group (n=50) which received 40mg/day SC for 14 days (for patients with normal renal function and body weight between 50 and 100kg) plus the conventional therapy of Covid-19 adopted by the Egyptian ministry of health for 15 days.

Drug: Enoxaparin, Hydroxychloroquine

Hydroxychloroquine group

ACTIVE COMPARATOR

The HCQ group which received 400 mg/day HCQ for five days plus the conventional therapy of Covid-19 adopted by the Egyptian ministry of health for 15 days(n=50).

Drug: Enoxaparin, Hydroxychloroquine

Enoxaparin plus Hydroxychloroquine group

ACTIVE COMPARATOR

The HCQ plus Enoxaparin combination group including 50 patients receiving combined therapy of 400 mg/day HCQ for five days and 40mg/day enoxaparin for 14 days plus the conventional therapy of COVID-19 adopted by the Egyptian ministry of health for 15 days

Drug: Enoxaparin, Hydroxychloroquine

Interventions

Enoxaparin, Hydroxychloroquine DRUG

To compare efficiency and safety of Enoxaparin and Hydroxychloroquine as monotherapy versus Polytherapy

Control group; Enaxoprin group; Enoxaparin plus Hydroxychloroquine group; Hydroxychloroquine group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-Suef University teaching Hospital

Banī Suwayf, Cairo Governorate, 62511, Egypt

Location

MeSH Terms

Conditions

COVID-19

Interventions

Enoxaparin; Hydroxychloroquine

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)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Pharmacy

Model Details: Study Patients were randomized into four parallel equal groups using a computerized random number generator using simple randomization with an equal allocation ratio. Two hundred and twenty patients were eligible. Twenty patients were excluded due to not meeting the inclusion criteria (n=14) or the decline to be enrolled in the study (n=4). The sample size was calculated by G.power version 3.1 for windows (Faul et al., 2009). With a priori calculating the sample size based on the length of stay among the studied groups using one way ANOVA test (F-test group), at an effect size (0.306), alpha probability (0.05) and power (95%), the calculated sample size was 184 in the 4 groups that increased to 200 (with 6% increase) to overcome the missing of data and dropout or loss of follow up.

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 5, 2022
• Study Start: June 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 30, 2021
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

EG (1)