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A Study to Evaluate the Safety and Efficacy of Artemisinin- a Herbal Supplement on COVID-19 Subjects

Primary Purpose

Covid19

Status

Completed

Phase

Phase 4

Locations

India

Study Type

Interventional

Intervention

Artemisinin

Dexamethasone

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female subjects of ≥18 to 60 years of age both inclusive
Subjects willing to give informed consent and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Confirmed case of COVID-19 infection by RT-PCR and mild and moderate (without oxygen therapy or assisted ventilation) cases of COVID-19. Scores of 2-4 on the WHO Clinical Progression Scale
Time interval between symptoms onset and randomization of no more than 7 days
One or more of the following symptoms:
Fever Cough Sore throat Headache Nasal congestion Malaise Diarrhea Loss of smell Loss of taste
Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 30 days after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.

Exclusion Criteria:

Subjects with history of severe infections (pneumonia, septicemia, etc.), severe cardiac or pulmonary diseases, or received immunosuppressive therapy or other investigational drugs within the previous 30 days of screening
Known or suspected hypersensitivity to Artemisinin
Women of child bearing potential who are currently pregnant, lactating or who are not willing to use contraception during the entire duration of the study
Men who are unwilling to use contraception while receiving investigational product
Subjects with history of severe disease other than COVID-19 which is expected to prevent compliance with the present protocol
Subjects with history of severe renal and hepatic impairment. (creatine ≥2 mg/dl; liver enzymes and bilirubin 2.5 times ULN; alkaline phosphatase 1.5 times ULN)
Recent treatment with Artemisinin or Artemisinin based antimalarials in the past 7 days
Known history of failure to control systemic fungal, bacterial or viral infection
Patients with the history of following co-morbidities: diabetes, hypertension with or without cardiac symptoms, morbid obesity with diabetes and/or hypertension or any other metabolic syndrome
Subjects with known human immunodeficiency virus (HIV) or hepatitis B or C classes of active viral infection
Have a history of neurological or psychiatric disorders, including epilepsy or dementia
Subjects for whom ventilator support is required at screening
Patients not willing to stay in hospital for 5 days of isolation following diagnosis of Covid-19
Subjects not willing to give their informed consent to participate in the clinical trial
According to the investigator judgment there are concomitant diseases with a serious safety hazard or affect the subject
Using other experimental drugs or participating in other clinical trials in the prior one month

Sites / Locations

Government Medical College & Government General Hospital, Srikakulam
Rajarshi Chhatrapati Shahu Maharaj Government Medical college and Chhatrapati Pramila Raje Hospital
Seven Star Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Artemisinin 500mg

Standard of Care

Arm Description

The dose regimen will be in cycles. In a cycle a subject will receive Artemisinin 500 mg capsule once daily plus SOC on Day 1 to Day 5 followed by 5 days off (no dosing of Artemisinin) or SOC alone. A subject can have a total of consecutive 3 cycles maximum. Here SOC is Standard of Care as per CLINICAL MANAGEMENT PROTOCOL: COVID-19, Government of India Ministry of Health and Family Welfare Directorate General of Health Services (EMR Division)

Standard of Care as per CLINICAL MANAGEMENT PROTOCOL: COVID-19, Government of India Ministry of Health and Family Welfare Directorate General of Health Services (EMR Division) Mild Patients: HYDROXYCHLOROQUINE Moderate Patients: Dexamethasone - OD for 05

Outcomes

Primary Outcome Measures

Safety Assessments

Incidence of adverse events during the study. Incidence of serious adverse events during the study.

Secondary Outcome Measures

Efficacy Assessments

Improvement rate in severity of COVID-19 per 8-point WHO COVID-19 Clinical Improvement Ordinal Scale. Improvement rate in severity of COVID-19 per the Duration of Symptoms. Clinical improvement is defined as • A rate decrease to categories 1, 2, 3, or 4.

Full Information

NCT ID

NCT05004753

First Posted

July 26, 2021

Last Updated

September 1, 2021

Sponsor

Mateon Therapeutics

Collaborators

Windlas Biotech Private Limited

1. Study Identification

Unique Protocol Identification Number

NCT05004753

Brief Title

A Study to Evaluate the Safety and Efficacy of Artemisinin- a Herbal Supplement on COVID-19 Subjects

Official Title

A Prospective, Randomized, Multi-center, Open Label, Interventional Study to Evaluate the Safety and Efficacy of Artemisinin 500 mg Capsule in Treatment of Adult Subjects With COVID-19

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

September 30, 2020 (Actual)

Primary Completion Date

February 28, 2021 (Actual)

Study Completion Date

April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mateon Therapeutics

Collaborators

Windlas Biotech Private Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This will be an open label, prospective, multi-center, comparative, interventional study to evaluate safety and efficacy of Artemisinin 500 mg in subjects with mild to moderate COVID-19. Initially subjects having mild to moderate COVID-19 will be screened as per predefined eligibility criteria for the study. Eligible 120 subjects will be enrolled to receive treatment with Artemisinin and SOC (Standard of Care as per CLINICAL MANAGEMENT PROTOCOL: COVID-19, Government of India Ministry of Health and Family Welfare Directorate General of Health Services (EMR Division)) or SOC. Subjects will be randomized in 2:1 ratio. Group 1 will have 80 subjects and Group 2 will have 40 subjects.

Detailed Description

The study will involve screening (Day 1), treatment period of up to maximum 28 days till end of study. The investigator shall make every effort to follow the schedule of study assessments and procedures. A window period of 1 day will be allowed for assessments post randomization. Screening Upon obtaining the written informed consent the subjects will be screened to confirm the eligibility for participating in this study. If RT PCR result is available for the subject then screening and baseline (randomization) activity will be on the same day. As per the Investigator discretion, the subjects meeting the criteria will be hospitalized for the first cycle of treatment Treatment period Subjects will receive investigational product and SOC after randomization as per protocol. Subject's compliance with the study treatment regimen of Artemisinin one (1) capsule a day for five (5) days, will be assessed during treatment period. Subjects receiving at least one dose of study treatment will be included in the safety analysis. Efficacy analysis will be conducted in completers (subjects who have completed at least 5 consecutive days of dosing in either arm) The first cycle of the study drug treatment will be given in the hospital, for which the subjects have to be hospitalized till Day 5, unless prolongation of hospital stay is necessary as per the investigator. On day 14, telephonic follow up is done for subjects discharged after Day 5. For Day 28 visit all subjects will visit the hospital to complete the End of Study activities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

2 to 1 ratio

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Artemisinin 500mg

Arm Type

Experimental

Arm Description

Arm Title

Standard of Care

Arm Type

Active Comparator

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Artemisinin

Intervention Description

a herbal supplement

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

corticosteroids

Primary Outcome Measure Information:

Title

Safety Assessments

Description

Incidence of adverse events during the study. Incidence of serious adverse events during the study.

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Efficacy Assessments

Description

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female subjects of ≥18 to 60 years of age both inclusive Subjects willing to give informed consent and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures Confirmed case of COVID-19 infection by RT-PCR and mild and moderate (without oxygen therapy or assisted ventilation) cases of COVID-19. Scores of 2-4 on the WHO Clinical Progression Scale Time interval between symptoms onset and randomization of no more than 7 days One or more of the following symptoms: Fever Cough Sore throat Headache Nasal congestion Malaise Diarrhea Loss of smell Loss of taste Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 30 days after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active. Exclusion Criteria: Subjects with history of severe infections (pneumonia, septicemia, etc.), severe cardiac or pulmonary diseases, or received immunosuppressive therapy or other investigational drugs within the previous 30 days of screening Known or suspected hypersensitivity to Artemisinin Women of child bearing potential who are currently pregnant, lactating or who are not willing to use contraception during the entire duration of the study Men who are unwilling to use contraception while receiving investigational product Subjects with history of severe disease other than COVID-19 which is expected to prevent compliance with the present protocol Subjects with history of severe renal and hepatic impairment. (creatine ≥2 mg/dl; liver enzymes and bilirubin 2.5 times ULN; alkaline phosphatase 1.5 times ULN) Recent treatment with Artemisinin or Artemisinin based antimalarials in the past 7 days Known history of failure to control systemic fungal, bacterial or viral infection Patients with the history of following co-morbidities: diabetes, hypertension with or without cardiac symptoms, morbid obesity with diabetes and/or hypertension or any other metabolic syndrome Subjects with known human immunodeficiency virus (HIV) or hepatitis B or C classes of active viral infection Have a history of neurological or psychiatric disorders, including epilepsy or dementia Subjects for whom ventilator support is required at screening Patients not willing to stay in hospital for 5 days of isolation following diagnosis of Covid-19 Subjects not willing to give their informed consent to participate in the clinical trial According to the investigator judgment there are concomitant diseases with a serious safety hazard or affect the subject Using other experimental drugs or participating in other clinical trials in the prior one month

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mukesh Kumar

Organizational Affiliation

Windlas Biotech Private Limited

Official's Role

Study Chair

Facility Information:

Facility Name

Government Medical College & Government General Hospital, Srikakulam

City

Srikakulam

State/Province

Andhra Pradesh

ZIP/Postal Code

532001

Country

India

Facility Name

Rajarshi Chhatrapati Shahu Maharaj Government Medical college and Chhatrapati Pramila Raje Hospital

City

Kolhapur

State/Province

Maharashtra

ZIP/Postal Code

431001

Country

India

Facility Name

Seven Star Hospital

City

Nagpur

State/Province

Maharashtra

ZIP/Postal Code

440009

Country

India

12. IPD Sharing Statement

Citations:

Citation

Trieu V, Saund S, Rahate PV, Barge VB, Nalk KS, Windlass H, Uckun FM. Targeting TGF-beta pathway with COVID-19 Drug Candidate ARTIVeda/PulmoHeal Accelerates Recovery from Mild-Moderate COVID-19. Clinical Investigation (2021) 11(1), 10-18

Results Reference

result

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A Study to Evaluate the Safety and Efficacy of Artemisinin- a Herbal Supplement on COVID-19 Subjects

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