Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: DWRX2003: Dose and dosage frequency: 960 mg divided into two consecutive doses on Day 1 (480 mg, intramuscular left deltoid) and Day 2 (480 mg, right deltoid)
Route of administration: I
Sponsors
Daewoong Pharmaceutical India Pvt Ltd
Mankind Research Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1.Over 18 years of age, inclusive, at time of signing the Informed Consent Form (ICF) 2.Patients who confirm COVID-19 positive by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) assay a week prior to randomization. 3. Clinical signs of pneumonia (fever, cough, dyspnea, fast breathing) or Imaging diagnosis of pneumonia plus one of the following: - Respiratory rate >=24 breaths/min, or; - Respiratory distress, or; - SpO2 4. Patients who agree to give written informed consent and are willing to participate in the study. 5. Patients who are hospitalized or admitted to the hospital or who are planned to be. 6. Patients who will be available for the entire study period and is capable of understanding and communicating with the investigators and clinical study facility staff. 7. Female patients who are having negative results in serum pregnancy test during screening, and urine pregnancy test at randomization 8. Female patients of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 60 days after their dose of study treatment (Preferably two methods). 9. Male patient and/or Female patientâ??s partner must agree to use condoms or should have undergone vasectomy or spermicide in addition to female contraception for additional protection against conception for 60 days after their dose of study treatment (Preferably two methods).
Exclusion criteria
Exclusion criteria: 1. Patients with critical medical conditions such as: A. Acute Respiratory Distress Syndrome (ARDS) B. Patient who is currently in an urgent crisis where invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) is needed. C. Evidence of sepsis, septic shock or multiple organ dysfunction/failure. 2. Patients receiving systemic corticosteroids within 15 days prior to screening 3. Patient who is positive or reactive for antibodies to HIV 1 and 2, hepatitis B & C, and Rapid Plasma Reagin (RPR) 4. Patient who is suspected to be positive for any respiratory tract viral/bacterial infection, or active tuberculosis within 14 days prior to screening. 5. Patient who was vaccinated (COVID-19 vaccine) prior to screening 6. Patients receiving or who have received antiviral therapy and anti- retroviral therapy within 28 days prior to screening visit, except patients who had stopped antiviral therapy for enough wash out period 7. Patient with uncontrolled respiratory disease other than COVID-19 pneumonia (i.e. Chronic Obstructive Pulmonary Disease, asthma, cystic fibrosis, etc.) 8. Patients with a history of uncontrolled congestive heart failure (New York Heart Association Classification of 3rd, and 4th grade), angina, myocardial infarction, cerebrovascular events, Coronary artery bypass graft (CABG), transient ischemic attack, or pulmonary embolism within 3 months to the administration of the investigational product. 9. Hypersensitivity to the investigational product and/or its component or emergency drugs for hypersensitivity (e.g. epinephrine). 10. Patient being treated for malignancy 11. Patient who has participated in any other clinical trial within 30 days prior to screening. 12. Patient who continuously requires immunosuppressants (i.e. Anti-TNFα inhibitors, interleukin inhibitors, any other immunosuppressants warranted after organ transplantation) 13. Patient who have blood clot disorders or bleeding tendency. 14. At screening, Creatinine clearance 15. At screening, Aspartate transferase (AST) or Alanine transferase (ALT) > 5x upper limit of normal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of Niclosamide injectable (DWRX2003) following multiple doses of DWRX2003 in moderate to severe COVID-19 patients.Timepoint: From Baseline to End of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy will be assessed by 1. Proportion of patients requiring mechanical ventilation (invasive mechanical ventilation) or extracorporeal membrane oxygenation (ECMO) or patients who die due to the aggravation of SARS-CoV-2 infection up till day 14, 28 2. Change from baseline in WHO clinical progression scale at day 4, 7, 10, 14, 21 and 28 3. Change from baseline in patients having WHO clinical progression scale of 5 or 6 at day 4, 7, 10, 14, 21 and 28 Timepoint: From Baseline to End of treatment;Efficacy will be assessed by 1. Proportion of patients whose National Early Warning Score 2 (NEWS2) has decreased from the baseline at day 4, 7, 10, 14, 21 and 28 2. Proportion of patients who achieve NEWS2 score 0 at day 4, 7, 10, 14, 21 and 28 3. The oxygenation period of patients with oxygen by mask or nasal prongs until day 28. 4. The oxygenation period of patients with non-invasive ventilation or high-flow oxygen until day 28. Timepoint: From Baseline to End of treatement;Efficacy will be assessed by 1. Proportion of patients whose World Health Organization (WHO) clinical progression scale has decreased by 1 or 2 from the baseline at day 4, 7, 10, 14, 21 and 28 2. The number of patients who achieve WHO clinical progression scale of 0 to 4 from the baseline at day 14, and 28. 3. The number of patients who achieve WHO clinical progression scale of 0 at day 14, and 28. 4. The number of patients who achieve WHO clinical progression scale of 1 at day 14, and 28. Timepoint: From Baseline to End of treatment;Efficacy will be assessed by 1. The oxygenation period of patients with intubation and mechanical ventilation, partial pressure of oxygen (pO2)/fraction of inspired oxygen (FiO2) â?¥150 or oxygen saturation (SpO2)/fraction of inspired oxygen (FiO2) â?¥200 until day 28. 2. Time to achieve WHO clinical progression scale of 0 to 4 from baselineTimepoint: From Baseline to End of treatment;Efficacy will be assessed by 1. The number of patients who a | — |
Countries
India
Contacts
Public ContactLakshmikanth Maddela
Daewoong Pharmaceutical (India) Pvt. Ltd.
Outcome results
None listed