Pegylated Interferon - α2b With SARSCoV- 2 (COVID-19)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04480138 |
Recruitment Status :
Terminated
(Due to non availability of eligible subjects and slow recruitment)
First Posted : July 21, 2020
Last Update Posted : July 12, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Covid19 | Drug: Pegylated Interferon-α2b Other: Standard of Care | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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) |
Actual Study Start Date : | August 11, 2020 |
Actual Primary Completion Date : | June 21, 2021 |
Actual Study Completion Date : | June 21, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Pegylated Interferon-α2b + 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. |
Drug: Pegylated Interferon-α2b
1 mcg/kg on day 1 and day 8 after safety evaluations. Other: Standard of Care Standard of care as per local authority |
Active Comparator: Standard of Care
Control: Standard of care Standard of care treatment will be provided as per regulatory recommendation and approval. |
Other: Standard of Care
Standard of care as per local authority |
- Change in Clinical status of subject on a 7-point ordinal scale [ Time Frame: Week 2 ]
- Not hospitalized, no limitations on activities.
- Not hospitalized, limitation on activities.
- Hospitalized, not requiring supplemental oxygen.
- Hospitalized, requiring supplemental oxygen.
- Hospitalized, on non-invasive ventilation or high flow oxygen devices.
- Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
- Death.
- PCR test [ Time Frame: Week 2 and Week 4 ]PCR for SARS-CoV-2 in pharyngeal swab
- Supplemental Oxygen [ Time Frame: Week 2 and Week 4 ]Occurrence of supplemental Oxygen
- Mechanical Ventilation [ Time Frame: Week 2 and Week 4 ]Occurrence of Mechanical Ventilation
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: Week 2 and Week 4 ]Occurence of Adverse events
- C-reactive protein (CRP) [ Time Frame: Week 2 and Week 4 ]Inflammatory Biomarker
- Interleukin 6 (IL-6) [ Time Frame: Week 2 and Week 4 ]Inflammatory Biomarker
- D-dimer [ Time Frame: Week 2 and Week 4 ]Inflammatory Biomarker
- Interferon gamma [ Time Frame: Week 2 and Week 4 ]type II class of interferons
- Ferritin [ Time Frame: Week 2 and Week 4 ]proteins
- TNF alpha [ Time Frame: Week 2 and Week 4 ]Inflammatory Biomarker
- Interleukin 1-β [ Time Frame: Week 2 and Week 4 ]Inflammatory Biomarker

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Ability to comprehend and willingness to sign a written ICF for the study.
- Male or non-pregnant females, ≥18 years of age at the time of enrolment.
- Understands and agrees to comply with planned study procedures.
- Agrees to the collection of pharyngeal swabs and blood sample as per protocol.
- Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen within one week
- Patients with SpO2 > 93% and respiratory rate <30 breaths/min.
-
Illness of any duration, and at least one of the following:
- Radiographic infiltrates by imaging (chest x-ray)
- Clinical assessment (evidence of rales/crackles or other clinical symptoms on exam).
- Women of childbearing potential must agree to use at least one primary form of contraception
Exclusion Criteria:
- ALT/AST >5 times the upper limit of normal.
- Patients with respiratory rate <20 breaths/min and normal SpO2 with confirmed SARS-CoV-2 infection as determined by PCR (Mild COVID-19 subjects).
- Patients with respiratory rate ≥30 breaths/min and SpO2 at rest ≤93% (Severe COVID-19 subjects).
- Stage ≥4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <30 mL/min/1.73 m2).
- Pregnant or breast feeding.
- Allergy to any study medication or usage of test drug during last 14 days prior to screening
- 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.
- Comorbid condition like myocardial infarction or heart failure within 90 days of recruitment.
- Prolong QT interval (>450 ms).

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): NCT04480138
Mexico | |
Avant Sante site 2 | |
Zapopan, Jalisco, Mexico | |
Avant Sante Site 1 | |
Monterrey, Mexico |
Study Director: | Dr Deven Parmar, MD | Cadila Healthcare Ltd. |
Responsible Party: | Cadila Healthcare Limited |
ClinicalTrials.gov Identifier: | NCT04480138 |
Other Study ID Numbers: |
PEGI.20.003 |
First Posted: | July 21, 2020 Key Record Dates |
Last Update Posted: | July 12, 2022 |
Last Verified: | June 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections |
Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Interferons Antineoplastic Agents Antiviral Agents Anti-Infective Agents |