A Clinical Trial Evaluating Niclosamide for the Treatment of Covid-19 Disease.

Phase 2

Active, not recruiting

Conditions: Other specified respiratory disorders, (2) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,

Registration Number: CTRI/2021/05/033791

Lead Sponsor: Laxai Life Sciences Pvt Ltd

Brief Summary: This is a Phase II, Randomized, Multi-centric, Open Label clinical study to evaluate the efficacy, safety & tolerability of Niclosamide when used alongside Standard of Care (SOC) for the treatment of hospitalized patients with coronavirus disease (COVID-19).

The proposed study is a two phase clinical study wherein first phase, i.e, Treatment Phase will began when either a male or female (non-pregnant, non-lactating) patients between 18 to 65 years (both inclusive) with clinically confirmed & documented diagnosis of moderate coronavirus disease (COVID-19) with severity rating of Grade 4 or Grade 5 at the time of study entry as per WHO ordinal score and who require hospitalization for management of the disease will be screened and enrolled for participation in the study as per study protocol.

The treatment period with investigational product in test group will be 7 days. It is however necessary that all patients in either test or control groups be allowed to take concomitant SOC as per the prescribed schedule for entire duration of the study, as applicable. Follow-up Phase shall begin from EOT (Day 8) and will continue for another 2 weeks for each patient. During Follow-up Phase, all patients in both test and/or control groups will take SOC as advised per individual treatment plan and will be asked to monitor signs & symptoms of disease, status of clinical recovery and adverse events, if any.

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: All

Target Recruitment: 96

Inclusion Criteria

Male & female (non-pregnant, non-lactating, post-menopausal, surgically sterilized, or practicing a reliable method of birth control during the duration of the study) patients with ages ranging from 18 to 65 years (both inclusive).
Clinically stable condition for at least 6 months before enrollment.
Confirmed diagnosis of moderate COVID-19 symptoms demonstrated by: Positivity in RT-PCR 2019-nCov test on respiratory tract (nasopharyngeal / oropharyngeal) specimens.
Presence of dyspnea and/or hypoxia, fever, cough, including SpO2 < 93% (range 90-93%) on room air, Respiratory Rate > 24 and < 30 breaths per minute.
Patients with SpO2 < 90% to be excluded from the study.
Signs of pneumonia (lung injury/lung involvement) confirmed by Chest X-Ray at the time of study entry.
Disease severity score between Grade 4 to 5 on the WHO 9-point ordinal scale & patient requires hospitalization for management of the disease.
Within 7 days from symptom onset or within 72 hours of laboratory diagnosis of SARS-CoV2 via RT-PCR test.
Able to take oral tablets at the time of study entry and agree not to participate in any other study for duration of participation in this study.
Willing to sign voluntary informed consent for participation in the study and willing to adhere to all protocol procedures.
In case the subject is unable to provide informed consent then the same should be obtained from a legally acceptable representative (LAR).

Exclusion Criteria

Subjects will be excluded from the study for any of the following reasons: Subjects with known allergy or hypersensitivity to Niclosamide or any of its components.
Patients who have previously had a disease severity score of 6 or 7 on the WHO 9-point ordinal scale.
Evidence of severe or critical illness, defined by at least 1 of the following: Respiratory failure requiring at least 1 of the following: Endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula Extracorporeal membrane oxygenation (ECMO) or clinical diagnosis of respiratory failure Shock (defined by systolic blood pressure (BP) <100 mm Hg, or diastolic blood pressure (BP) <60 mm Hg or requiring vasopressors), OR Multi-organ dysfunction/failure Subjects with Chronic liver disease (Child-Pugh class B or C) and chronic renal disease (GFR<30ml/min).
Renal dysfunction [Serum Creatinine > 2.5 times of ULN or calculated creatinine clearance < 30ml/min], Liver Dysfunction [Total Bilirubin > 3times ULN & AST/ALT >5times ULN].
Subjects with oxygen saturation (SpO2) â‰¤90%.
Respiration Rate â‰¥30 breaths per minute at the time of enrolment.
History of refractory nausea, vomiting, or chronic gastrointestinal disorders, inability to swallow the study drug, or having undergone extensive bowel resection which may affect adequate absorption of study medications.
Inability to swallow tablets (administration via nasogastric tube is permitted in patients who become unable to swallow after starting the study drug).
Patients who require IL-6 inhibitors for management of inflammation at the time of study entry.
Female subjects who are pregnant or involved in breastfeeding.
Subject was using adrenocorticosteroids (except topical or inhaled preparations) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists, or interleukin receptor blockers) within one week prior to study entry.
Subject has a serious chronic disease (e.g., human immunodeficiency virus (HIV), hepatitis B virus or hepatitis C virus, cancer requiring chemotherapy within the preceding 6 months, unstable cardiac, pulmonary, neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days.
Has a history of alcohol or drug abuse in the previous 6 months.
Subject has a psychiatric disease that is not well controlled where controlled is defined as stable on a regimen for more than one year.
Subject already treated with another COVID 19 therapy but has relapsed with a positive diagnosis.
Hospital discharge is anticipated in â‰¤24 hours.
Anticipated transfer to another hospital which is not a study site within 72 hours.
Participated in any other clinical trial or taken an investigational drug within 1 month.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to Clinical Improvement of 2-points on WHO 8-Point Ordinal Scale	Baseline, Day 03, Day 05, Day 07, Day 14, Day 21

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measures for this study will include:	Time to respiratory viral clearance

Trial Locations

Locations (8): Aarupadai Veedu Medical College and Hospital
🇮🇳
Pondicherry, PONDICHERRY, India
Bangalore Medical College and Research Institute
🇮🇳
Bangalore, KARNATAKA, India
Noorul Islam Institute of Medical Science (NIMS) and Research Foundation
🇮🇳
Thiruvananthapuram, KERALA, India
PCMCs PGI Yashwant Rao Chavan Memorial Hospital
🇮🇳
Pune, MAHARASHTRA, India
RCSM Government Medical College and CPR Hospital
🇮🇳
Kolhapur, MAHARASHTRA, India
Santosh Medical College Hospital
🇮🇳
Ghaziabad, UTTAR PRADESH, India
SMS Medical College & Attached Hospital
🇮🇳
Jaipur, RAJASTHAN, India
Vijaya Super Speciality Hospital
🇮🇳
Nellore, ANDHRA PRADESH, India
Aarupadai Veedu Medical College and Hospital
🇮🇳Pondicherry, PONDICHERRY, India
Dr A Thumjaa
Principal investigator
914132615246
thumjaa@gmail.com