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Due to non availability of eligible subjects and slow recruitment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pegylated Interferon-α2b + Standard of care | Experimental | 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 | Active Comparator | Control: Standard of care Standard of care treatment will be provided as per regulatory recommendation and approval. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated Interferon-α2b | Drug | 1 mcg/kg on day 1 and day 8 after safety evaluations. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical status of subject on a 7-point ordinal scale |
| Week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| PCR test | PCR for SARS-CoV-2 in pharyngeal swab | Week 2 and Week 4 |
| Supplemental Oxygen | Occurrence of supplemental Oxygen | Week 2 and Week 4 |
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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:
Women of childbearing potential must agree to use at least one primary form of contraception
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Deven Parmar, MD | Cadila Healthcare Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avant Sante site 2 | Zapopan | Jalisco | Mexico | |||
| Avant Sante Site 1 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care | Other | Standard of care as per local authority |
|
| Mechanical Ventilation | Occurrence of Mechanical Ventilation | Week 2 and Week 4 |
| Incidence of Treatment-Emergent Adverse Events | Occurence of Adverse events | Week 2 and Week 4 |
| C-reactive protein (CRP) | Inflammatory Biomarker | Week 2 and Week 4 |
| Interleukin 6 (IL-6) | Inflammatory Biomarker | Week 2 and Week 4 |
| D-dimer | Inflammatory Biomarker | Week 2 and Week 4 |
| Interferon gamma | type II class of interferons | Week 2 and Week 4 |
| Ferritin | proteins | Week 2 and Week 4 |
| TNF alpha | Inflammatory Biomarker | Week 2 and Week 4 |
| Interleukin 1-β | Inflammatory Biomarker | Week 2 and Week 4 |
| Monterrey |
| Mexico |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |