A clinical trial to study the effects of DWRX2003 (Niclosamide IM Depot Injection) in COVID-19 patients

Phase 1

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

• Registration Number: CTRI/2021/07/034522
• Lead Sponsor: Daewoong Pharmaceutical India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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 < 94% on room air

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

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 < 30 mL/min, or Estimated Glomerular Filtration Rate (eGFR) <30 mL/min/1.73ã?¡ (by Cockcroft-Gault equation)

15. At screening, Aspartate transferase (AST) or Alanine transferase (ALT) > 5x upper limit of normal

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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