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

Covid19 Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04480138
• Other study ID #: PEGI.20.003
• Status: Terminated
• Phase: Phase 2
• Start date: August 11, 2020
• Est. completion date: June 21, 2021

Study information

• Verified date: June 2021
• Source: Cadila Healthcare Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: June 21, 2021
• Est. primary completion date: June 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• Pegylated Interferon-a2b
1 mcg/kg on day 1 and day 8 after safety evaluations.

Other:
• Standard of Care
Standard of care as per local authority

Locations

Country	Name	City	State
Mexico	Avant Sante Site 1	Monterrey
Mexico	Avant Sante site 2	Zapopan	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Cadila Healthcare Limited

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Clinical status of subject on a 7-point ordinal scale	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.	Week 2
Secondary	PCR test	PCR for SARS-CoV-2 in pharyngeal swab	Week 2 and Week 4
Secondary	Supplemental Oxygen	Occurrence of supplemental Oxygen	Week 2 and Week 4
Secondary	Mechanical Ventilation	Occurrence of Mechanical Ventilation	Week 2 and Week 4
Secondary	Incidence of Treatment-Emergent Adverse Events	Occurence of Adverse events	Week 2 and Week 4
Secondary	C-reactive protein (CRP)	Inflammatory Biomarker	Week 2 and Week 4
Secondary	Interleukin 6 (IL-6)	Inflammatory Biomarker	Week 2 and Week 4
Secondary	D-dimer	Inflammatory Biomarker	Week 2 and Week 4
Secondary	Interferon gamma	type II class of interferons	Week 2 and Week 4
Secondary	Ferritin	proteins	Week 2 and Week 4
Secondary	TNF alpha	Inflammatory Biomarker	Week 2 and Week 4
Secondary	Interleukin 1-ß	Inflammatory Biomarker	Week 2 and Week 4