Slctr

Randomized double blind placebo controlled trial of the safety and efficacy of investigational herbal preparations for the treatment of patients with COVID-19

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SLCTR Registration Number

SLCTR/2021/008

Date of Registration

15 Mar 2021

The date of last modification

Mar 16, 2021

Application Summary

Scientific Title of Trial

Randomized double blind placebo controlled trial of the safety and efficacy of investigational herbal preparations for the treatment of patients with COVID-19

Public Title of Trial

Randomized double blind controlled trial to assess the safety and efficacy of three investigational herbal preparations (nut meg based preparation, sudarshana churna, coriandum based preparation) for the treatment of patients with COVID-19

Disease or Health Condition(s) Studied

COVID 19

Scientific Acronym

SEPC- COVID Trial

Public Acronym

SEPC- COVID trial

Brief title

Randomized double blind controlled trial of the safety and efficacy of investigational herbal preparations for the treatment of patients with COVID-19

Universal Trial Number

U1111-1262-6931

Any other number(s) assigned to the trial and issuing authority

2020/EC/75; ERC, UoP

Trial Details

What is the research question being addressed?

Are the three investigational herbal preparations (Nut meg based preparation, sudarshana churna, coriandum based preparation) safe and effective in treating COVID 19 patients?

Type of study

Interventional

Study design

Allocation

Randomized controlled trial

Masking

Double blinded : Participants, Investigators, Data analysts, Healthcare providers, Outcome assessors

Control

Placebo

Assignment

Parallel

Purpose

Treatment

Study Phase

Phase 2

Intervention(s) planned

This study will be conducted at the Covid Centre, Base Hospital Theldeniya, Sri Lanka. Patients who fulfill the inclusion criteria will be randomized into four groups using computer-generated random numbers. Three groups will receive the investigational herbal products A, B and C. Product A (syrup made of Myristica fragrance, zingiber officinale, foeniculum vulgare and Bees’ honey), Product B (Atmospheric pressure hot water extraction of a powder made of Sudarshana churnaya (Ingredients found in Ayurveda Pharmacopoeia of Sri Lanka and Bees Honey)), Product C (Atmospheric pressure hot water extraction of coriandum sativum.) These will be given 15 ml twice daily for for 3 days, and the other group will receive a placebo containing sucrose syrup. 15 ml twice daily for 3 days. All groups will receive standard treatment according to the Ref. Circular no. Epid/400/2019n-cov, Ministry of Health, Sri Lanka. According to the present guideline, patients will be discharged after 14 days or more (Ref. Circular no. DDG/LS/CV-GL/2020, Ministry of Health,, Sri Lanka).

Inclusion criteria

Patients who understands and agrees to comply with planned study procedures.
Patients who agree to the collection of nasopharyngeal swabs and venous blood per protocol.
Male >18 years or non-pregnant female adult >18 years of age at the time of enrolement.
Has a laboratory confirmed SARS-CoV-2 infection as determined by positive PCR done within 72 hrs, with a quantitative PCR cycle threshold (qPCR Ct value ) which is less than 25 and a positive Rapid antigen testing (RAT) performed at the point of admission.

Exclusion criteria

Known patients with chronic liver disease and kidney disease
Alanine amino transferase (ALT) or Aspartate amino transferase (AST) or Serum creatinine> 2 times the upper limit of normal.
Pregnancy or breast feeding.
Anticipated transfer to another hospital which is not a study site within 72 hours.
Allergy to any study medication
Treatment with another investigational drug or other intervention
Patients who are on warfarin, glucocorticoids and other immuno-suppressive medications or anti-cancer medications
Patients with known substance abuse

Primary outcome(s)

1. Percentage reduction of viral burden as measured by quantitative PCR cycle threshold values and negative percentage of rapid antigen testing (RAT ) of naso pharyngeal swabs.	[ D4 and D7 from the starting day of intervention ]
2. Clinical improvement as assessed by 10 point ordinal scale -Mean change in the clinical status 10 point ordinal scale from Day 1 to Days 4, and 7 (Ref Ramdesivir for treament of COVID 19 N Engl J Med 2020; 383:1813-1826 ,DOI: 10.1056/NEJMoa2007764)	[ D4 and D7 from the starting day of intervention ]
3. Clinical improvement and clinical progression Clinical improvement as assessed by % change for National Early Warning Score (NEWS): Change from Day 1 to Days 4 and 7 in NEWS. Clinical progression using the WHO ordinal outcome scale – (WHO Working Group on the Clinical characterizations and Management of COVID-19 infection. A minimal common outcome measure set for COVID-19 clinical research. Lancet Infect Dis 2020. Published Online June 12, 2020. https://doi.org /10.1016/S1473-3099(20)30483-7)	[ D4 and D7 from the starting day of intervention ]
4. Percentage Improvement in white cell count, ALT, and AST, creatinine, CRP (C reactive protein), D Dimers, ferritin over time from D1 through D4 to D7	[ D4 and D7 from the starting day of intervention ]
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Secondary outcome(s)

1. Adverse reaction profile, As assessed clinically on a daily basis from D1 to D7 Clinical assessment will be done using a symptom questionnaire. (Ref Ramdesivir for threament of COVID 19 N Engl J Med 2020; 383:1813-1826 ,DOI: 10.1056/NEJMoa2007764)	[ From D4 and D7 from starting the intervention ]
2. Adverse reaction profile on biochemical assessment on D4 and D7 (compared with baseline on D1) Percentage Change in white cell count, haemoglobin, platelets, creatinine, glucose, total bilirubin, ALT, and AST, creatinine, CRP, D Dimers, ferritin over time from D1 through D4 to D7	[ From D4 and D7 from starting the intervention ]
3. Duration of hospitalization (days).	[ Assessed at D7, D14, D28 from the day of intervention ]
4. Proportion of patients with positive antibody response assessed using COVID antibody testing	[ Assessed at D7 from the day of intervention ]
5. Mortality (if any) • 07-day mortality and cause of death • 28-day mortality and cause of death	[ Assessed at D7 and D28 from the day of intervention ]
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Target number/sample size

112 (28 in each group)

Countries of recruitment

Sri Lanka

Anticipated start date

2021-03-15

Anticipated end date

2021-06-01

Date of first enrollment

Date of study completion

Recruitment status

Pending

Funding source

None

Regulatory approvals

CLITRI/2021/00046

State of Ethics Review Approval

Status

Approved

Date of Approval

2021-02-17

Approval number

2020/EC/75

Details of Ethics Review Committee

Name:	Ethics Review Committee of the Faculty of Medicine, University of Peradeniya
Institutional Address:	Ethics Review Committee of the Faculty of Medicine, University of Peradeniya, Faculty of Medicine, University of Peradeniya
Telephone:	081-2396361
Email:	chairpersonierc@gmail.com

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

H.M.T.W.seneviratne
Senior lecturer
Faculty of Medicine, University of Peradeniya
94 -812396386
0718232241

thilanka.medi@gmail.com

Contact Person for Public Queries

H.M.T.W.seneviratne
Senior lecturer
Faculty of Medicine, University of Peradeniya
94 -812396386
0718232241

thilanka.medi@gmail.com

Primary study sponsor/organization

University of Peradeniya

Secondary study sponsor (If any)

Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

Yes

IPD sharing plan description

Individual participant data that underlie the results reported in the publication of results will be shared after de-identification (text, tables, figures, and appendices). The study protocol and Statistical Analysis Plan will be shared. Data will be available beginning 3 months and ending 5 years following article publication.Data will be shared to achieve the aims in an approved proposal. Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose. Data will be available for individual participant data meta-analysis. Data will be available for proposals submitted up to 36 months following publication of results.

Study protocol available

Yes

Protocol version and date

2.1

Protocol URL

Results summary available

Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results