Clinical Trials to Assess Safety and Efficacy of DWRX2003 Combination With Remdesivir in Moderate to Severe COVID-19 Patients.
Tahapan Penelitian : Awal
Badan Kebijakan Pembangunan Kesehatan (BKPK) dan Daewoong Pharmaceutical Co. LTD
INA-RESPOND, Dr. Hasan Sadikin Hospital, Dr. Cipto Mangunkusumo Hospital & RSPAL dr. Ramelan
Tanggal Input Registry : 28-03-2022
|Tanggal Antisipasi Studi||01-02-2022|
|Outcome Primer||Safety Endpoint 1.Systemic adverse events and local adverse not related to injection site: TEAE, Serious Adverse Event (SAE), Adverse Event Special Interest (AESI; anaphylaxis), Adverse Drug Reaction (ADR), and Serious Adverse Drug Reaction (SADR) 2.Adverse events of injection site (Pain, Tenderness, Erythema, Induration/Edema, Urticaria, Pruritus, Other unspecified symptoms) performed on Day 1, 4, 7, 10, 14, 21, and 28. 3.Laboratory Tests, Vital Signs, Oxygen Saturation, Electrocardiogram (ECG), and Physical Examination Efficacy Endpoint The proportion of subjects requiring mechanical ventilation and invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) till day 14.|
|Outcome Skunder||Secondary Endpoints [WHO Clinical Progression Scale] 1. Change in WHO clinical progression scale from baseline to day 4, 7, 10, 14, 21 and 28. 2. Change in WHO clinical progression scale from baseline, in patients having of 5 or 6, to day 4, 7, 10, 14, 21 and 28. 3. Time to achieve WHO clinical progression scale of 0 to 4 from baseline. 4. The proportion of subjects whose WHO clinical progression scale has decreased by 1 or 2 from the baseline at day 4, 7, 10, 14, 21 and 28. 5. The number of subjects achieved WHO clinical progression scale of 0 to 4 at day 14, and 28. 6. The number of patients achieved WHO clinical progression scale of 0 at day 14, and 28. 7. The proportion of subjects achieved WHO clinical progression scale of 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, respectively, at day 4, 7, 10, 14, 21 and 28. [National Early Warning Score 2 (NEWS2)] 8. Change in NEWS2 from baseline to day 4, 7, 10, 14, 21 and 28. 9. The proportion of subjects whose NEWS2 has decreased from the baseline at day 4, 7, 10, 14, 21 and 28. 10. The proportion of subjects achieved NEWS2 score 0 at day 4, 7, 10, 14, 21 and 28. [Oxygenation] 11. The proportion of subjects requiring mechanical ventilation (invasive mechanical ventilation) or extracorporeal membrane oxygenation (ECMO) or subjects who die due to the aggravation of SARS-CoV-2 infection up till day 14, 28. 12. The oxygenation period of subjects with oxygen by mask or nasal prongs and with non-invasive ventilation or high-flow oxygen until day 28. 13. The oxygenation period of subjects with intubation and mechanical ventilation, pO2/FiO2 ≥150 or SpO2/FiO2 ≥200 until day 28. [Virus] 14. The SARS-CoV-2 negative proportion by RT-PCR at day 4, 7, 14, 21, and 28 by the nasopharyngeal specimen. [Others] 15. Hospitalization period. 16. The proportion of patients on Corticosteroids during the study and period of Corticosteroid use. Exploratory endpoint Change from baseline in White Blood Cells (WBC), Interleukin-6 (IL-6), Lymphocyte counts, and C-reactive protein (CRP) at day 7, 14 and 28.|
|Judul Penelitian Popular||Clinical Trials to Assess Safety and Efficacy of DWRX2003 Combination With Remdesivir in Moderate to Severe COVID-19 Patients.|
|Judul Penelitian Ilmiah||A Phase 2, Double Blind, Randomized, Placebo Controlled, Multi-center Study to Evaluate the Safety and Efficacy of DWRX2003 in Combination With Remdesivir Following Intramuscular Administration in Moderate-Severe COVID-19 Patients|
|Intervensi||Arm 1 = Niclosamide 432mg (i.m.) + Remdesivir Arm 2 = Niclosamide 960mg (i.m.) + Remdesivir Arm 3 = Placebo (i.m.) + Remdesivir|
|Jumlah Subyek Penelitian||60|
Inclusion Criteria:1. Age ≥ 18 years at time of signing the Informed Consent Form (ICF). 2. SARS-CoV-2 infection documented by RT-PCR within 7 days prior to randomization. 3. Hospitalized patients who meet the criteria of moderate or severe COVID-19. 4. Patients who are not pregnant, based on urine pregnancy test during screening, and randomization. 5. Female patients of childbearing potential 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). 6. Male patient and/or Female patient’s partner 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). 7. Patients who are anticipated to available for the entire study period and is capable of understanding and communicating with the investigators and clinical study facility staff. 8. Patients who agree to give written informed consent and are willing to participate in the study.
Exclusion Criteria:1. Patients with BMI ≥30. 2. Critical patients, such as (but not limited to); Acute Respiratory Distress Syndrome (ARDS), patient who is currently in an urgent crisis where invasive mechanical ventilation and/or ECMO is needed, evidence of sepsis, septic shock or multiple organ dysfunction/failure. 3. Patients receiving or who have received antiviral therapy and antiretroviral therapy within 28 days prior to the screening visit. 4. Patients with uncontrolled respiratory disease other than COVID-19 pneumonia (i.e. COPD, asthma, cystic fibrosis, etc.). 5. Patients with a history of uncontrolled condition with congestive HF (New York Heart Association (NYHA) Classification of 3rd, and 4th grade), angina, myocardial infarction, cerebrovascular events, CABG, transient ischemic attack, or pulmonary embolism within 6 months to the administration of the investigational product. 6. Patients who Hypersensitivity to the investigational product and/or its component or emergency drugs for hypersensitivity (e.g. epinephrine). 7. Patients who cannot be administered intramuscularly to bilateral ventro-gluteal area. 8. Patients who have fully recovered from malignancy within 5 years. 9. Patients who have participated in any other clinical trial within 30 days prior to screening. 10. Patients who continuously requires immunosuppressants (i.e. Anti-TNFα inhibitors, interleukin inhibitors, any other immunosuppressants warranted after organ transplantation). 11. Patients who have coagulation disorder. 12. eGFR < 30 mL/min/1.73 m2 (by MDRD equation), at screening. 13. AST and/or ALT > 5x upper limit of normal, at screening.
|Nomor Persetujuan Etik||1067/UN2.F1/ETIK/PPM.00.02.2021 dated 5 January 2022|
|Nomor Persetujuan Material Transfer Agreement||Not Applicable|
|Nomor Persetujuan Pelaksanaan Uji Klinik||National Agency of Drug and Food Control of Republic of Indonesia No. RG.01.06.1.3.01.22.01 dated 5 January 2022|
|Other Study ID Numbers||DW_DWJ1516202|
|Contact Person||Dr. Muhammad Karyana, MPH|