Efficacy of Sofosbuvir Plus Ledipasvir in Egyptian Patients With COVID-19 Compared to Standard Treatment

NCT04530422 | Completed Phase 3 DMC

• 1 other identifier: 14
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Currently there is no known effective therapy or vaccine for treatment of SARS-CoV-2, highlighting urgency around identifying effective therapies. This study aiming to evaluate the anti-HCV medications efficacy "Sofosbuvir-Ledipasvir" in treatment of moderate cases with SARS-COV-2 infection, in comparison to the standard treatment (hydroxychloroquine, oseltamivir and azithromycin).

Conditions

Covid19

Keywords

SARS-COV-2; Covid-19; Sofosbuvir- Ledipasvir; Hydroxychloroquine

Outcome Measures

Primary Outcomes (2)

• Therapeutic success (cured)

  Cured: Documented virological clearance in 2 samples at least 24 hours apart.

  21 days

• 28 days in hospital mortality

  any incidence of deaths for any participant within 28 days from starting the treatments

  28 days

Secondary Outcomes (3)

• Percentage of clinical failure of treatments

  21 Days

• Length of hospital stay

  Through study completion, an average of 14 weeks

• Incidence of side effects

  21 days

Study Arms (2)

• Group I (Sofosbuvir plus Ledipasvir)

EXPERIMENTAL

Patients assigned to this group (125 patients) were received Sofosbuvir plus Ledipasvir, once daily for 15 to 21 days as minimum and maximum duration of therapy, respectively.

Drug: Sofosbuvir plus Ledipasvir

Group II (Oseltamivir plus HCQ & Azithromycin)

ACTIVE COMPARATOR

Patients in this group (125 patients) were received the local medical committee of Almaza Fever Hospital guided standard treatment protocol for COVID-19: * Oseltamivir 150 mg q 12 hours for 10 days ; * HCQ 400 q 12 hours for one day followed by 200mg q 12 hours for 9 days ; and * Azithromycin 500mg once daily for 1 day , followed by 250mg once daily for 6 days. * Additional conservative medications were also given. Patients were evaluated as scheduled on day 0, 5 \& 11 clinically

Drug: Sofosbuvir plus Ledipasvir

Interventions

Sofosbuvir plus Ledipasvir DRUG

Sofosbuvir plus Ledipasvir, once daily for 15 to 21days * Oseltamivir 150 mg q 12 hours for 10 days ; * HCQ 400 q 12 hours for one day followed by 200mg q 12 hours for 9 days ; and * Azithromycin 500mg once daily for 1 day , followed by 250mg once daily for 6 days.

Also known as: Oseltamivir plus Hydroxychloroquine & Azithromycin

Group II (Oseltamivir plus HCQ & Azithromycin); • Group I (Sofosbuvir plus Ledipasvir)

Eligibility Criteria

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

You may qualify if:

• Pneumonic patients with SARS-COV-2 infection confirmed to be positive by RT-PCR; and demonstrated moderate cases criteria (fever "measured temperature of at least 38 °C", lower respiratory symptoms "cough, shortness of breath" and imaging-confirmed pneumonia").
• Female patients enrolled in the study should have no planned pregnancy for 6 months, after participating in the study, with administration of proper contraceptive measures within 30 days from the first therapeutic dose of the investigational drugs.
• Patients agreed to sign an informed consent to participate in the current study and that they would not participate in other clinical trials within 30 days from the last administration of the study drugs.

You may not qualify if:

• Severe COVID-19 patients who met one of the following conditions: (1) Respiratory rate (RR) ≥ 30 times / min; (2) SaO2 / SpO2 ≤ 93% in resting state; (3) arterial partial pressure of oxygen (PaO2) / concentration of oxygen (FiO2) ≤ 300 mmHg
• Critical COVID-19 patients with one of the following conditions: (1) respiratory failure and need mechanical ventilation; (2) shock; (3) other organ failure combined with ICU treatment; severe liver disease (such as child Pugh score ≥ C, AST \> 5 times upper limit);
• Patients with contraindications specified for sofosbuvir- ledipasvir; the pregnancy test of female subjects during the screening period was positive, the researchers judged that the patient was not suitable to participate in this clinical study due to devastating co-morbid diseases (e.g. de-compensated liver disease, congested heart failure, chronic kidney disease, malignant or hematological disease under therapy or 3 months ago) and patients received antiviral eradication therapy for hepatitis C or B viruses within the previous 6 months.
• Patients with chloroquine contra-indications: QTc \> 500 m/sec, myasthenia gravis, porphyria, retinal pathology, epilepsy, G6PD deficiency, allergy to 4-aminoquinolone, chronic heart, kidney or liver disease, and arrhythmias.
• Treatment was terminated at any time by a multidisciplinary team if a serious side effect occurred, which was attributed to the medications used ,e.g. cardiac arrhythmia, deteriorated liver or kidney function or unfortunately patient died .

Sponsors & Collaborators

• Almaza Military Fever Hospital: lead

Study Sites (1)

Almaza Military Fever Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

COVID-19

Interventions

Sofosbuvir; ledipasvir; Oseltamivir; 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)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Erythromycin; Macrolides; Polyketides; Lactones

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Randomization applied through computer-generated number and concealed using sequentially numbered, sealed opaque envelope to assign the patient to group 1 either group 2
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Almaza Military Fever Hospital

Model Details: This randomized controlled clinical trial is a prospective, comparative, single blind, randomized study that was conducted on 250 patients, divided into two equal groups. The group I received Sofosbuvir plus Ledipasvir and Group II received Oseltamivir, hydroxychloroquine "HCQ" plus Azithromycin (the local medical committee of Almaza Fever Hospital guided standard treatment protocol for COVID-19)

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: August 28, 2020
• Study Start: April 15, 2020
• Primary Completion: July 8, 2020
• Study Completion: July 23, 2020
• Last Updated: August 28, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)