Pegylated Interferon - α2b With SARSCoV- 2 (COVID-19)

Phase 2

Terminated

• Conditions: Covid19
• Interventions: Drug: Pegylated Interferon-α2b; Other: Standard of Care

• Registration Number: NCT04480138
• Lead Sponsor: Zydus Lifesciences Limited

Brief Summary

This is a phase II, multicenter, open-label, randomized, comparator-controlled study to evaluate the efficacy and safety of Pegylated Interferon -α2b in the treatment of adult patients diagnosed with SARS-CoV2 (COVID-19).Initial 1 mcg/kg of Pegylated Interferon-α2b will be administered on day 1. After safety evaluation of first dose, next dose (second dose) 1 mcg/kg on day 8 will be administered with recommended standard care during the trial.

Detailed Description

This is a phase II, multicenter, open-label, randomized, comparator-controlled study to evaluate the efficacy and safety of Pegylated Interferon -α2b in the treatment of adult patients diagnosed with SARS-CoV2 (COVID-19).Moderate COVID-19 subjects will be randomly assigned to receive test arm or reference arm in a 1:1 ratio.

Study Timeline

• Study First Submitted: 2020-07-20
• Study First Submitted QC: 2020-07-20
• Study First Posted: 2020-07-21
• Study Start: 2020-08-11
• Status Verified: 2021-06
• Primary Completion: 2021-06-21
• Study Completion: 2021-06-21
• Last Update Submitted: 2022-07-08
• Last Update Posted: 2022-07-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

1. Ability to comprehend and willingness to sign a written ICF for the study.

2. Male or non-pregnant females, ≥18 years of age at the time of enrolment.

3. Understands and agrees to comply with planned study procedures.

4. Agrees to the collection of pharyngeal swabs and blood sample as per protocol.

5. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen within one week

6. Patients with SpO2 > 93% and respiratory rate <30 breaths/min.

7. Illness of any duration, and at least one of the following:

   1. Radiographic infiltrates by imaging (chest x-ray)
   2. Clinical assessment (evidence of rales/crackles or other clinical symptoms on exam).

8. Women of childbearing potential must agree to use at least one primary form of contraception

Exclusion Criteria

1. ALT/AST >5 times the upper limit of normal.
2. Patients with respiratory rate <20 breaths/min and normal SpO2 with confirmed SARS-CoV-2 infection as determined by PCR (Mild COVID-19 subjects).
3. Patients with respiratory rate ≥30 breaths/min and SpO2 at rest ≤93% (Severe COVID-19 subjects).
4. Stage ≥4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <30 mL/min/1.73 m2).
5. Pregnant or breast feeding.
6. Allergy to any study medication or usage of test drug during last 14 days prior to screening
7. Severe co-morbidity (e.g. uncontrolled hypertension and uncontrolled DM, systemic disease which affect the vital organs severity, immunocompromised patients etc.) as per investigator's assessment.
8. Comorbid condition like myocardial infarction or heart failure within 90 days of recruitment.
9. Prolong QT interval (>450 ms).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pegylated Interferon-α2b + Standard of care	Pegylated Interferon-α2b	Test :- Pegylated Interferon-α2b + Standard of care (SOC) Pegylated Interferon-α2b-Initial 1 mcg/kg will be administered on day 1. After safety evaluation of first dose, next dose (second dose) 1 mcg/kg on day 8 will be administered along with the recommended standard of care at the time of conduct of trial.
Pegylated Interferon-α2b + Standard of care	Standard of Care	Test :- Pegylated Interferon-α2b + Standard of care (SOC) Pegylated Interferon-α2b-Initial 1 mcg/kg will be administered on day 1. After safety evaluation of first dose, next dose (second dose) 1 mcg/kg on day 8 will be administered along with the recommended standard of care at the time of conduct of trial.
Standard of Care	Standard of Care	Control: Standard of care Standard of care treatment will be provided as per regulatory recommendation and approval.

Primary Outcome Measures

Name	Time	Method
Change in Clinical status of subject on a 7-point ordinal scale	Week 2	1. Not hospitalized, no limitations on activities.; 2. Not hospitalized, limitation on activities.; 3. Hospitalized, not requiring supplemental oxygen.; 4. Hospitalized, requiring supplemental oxygen.; 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices.; 6. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).; 7. Death.

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	Week 2 and Week 4	Occurence of Adverse events
Mechanical Ventilation	Week 2 and Week 4	Occurrence of Mechanical Ventilation
PCR test	Week 2 and Week 4	PCR for SARS-CoV-2 in pharyngeal swab
Supplemental Oxygen	Week 2 and Week 4	Occurrence of supplemental Oxygen
C-reactive protein (CRP)	Week 2 and Week 4	Inflammatory Biomarker
Interleukin 6 (IL-6)	Week 2 and Week 4	Inflammatory Biomarker
D-dimer	Week 2 and Week 4	Inflammatory Biomarker
Interferon gamma	Week 2 and Week 4	type II class of interferons
Ferritin	Week 2 and Week 4	proteins
TNF alpha	Week 2 and Week 4	Inflammatory Biomarker
Interleukin 1-β	Week 2 and Week 4	Inflammatory Biomarker

Trial Locations

Locations (2)

Avant Sante site 2; 🇲🇽 Zapopan, Jalisco, Mexico

Avant Sante Site 1; 🇲🇽 Monterrey, Mexico