Clinical trial NCT05277155: Trial to Study the Efficacy and Safety of BEJO Red Ginger in COVID-19 Patients With Mild Symptoms
Official title: A Randomized, Controlled and Double-blinded Clinical Trial to Investigate the Efficacy and Safety of BEJO Red Ginger as an Adjuvant Therapy in COVID-19 Hospitalized Patients With Mild Symptoms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: COVID-19
Lead sponsor: Research Center for Chemistry, National Research and Innovation Agency of Indonesia
Sponsor class: OTHER_GOV
Collaborators: name: National Research and Innovation Agency of Indonesia
name: RSDC Wisma Atlet
name: PT. Bintang Toedjoe
First posted: 2022-03-14
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patient will be randomized 1:1 to placebo with SOC and BEJO Red Ginger with standard of care (SOC).
Primary purpose: TREATMENT

Brief summary: This study is a randomized, double-blind, placebo-controlled clinical trial to investigate the safety and efficacy of BEJO Red Ginger in hospitalized adult (18 - 50 years old) COVID-19 patients with mild clinical manifestations.

Subjects will be screened during hospitalization. One hundred and sixty-eight patients with confirmed SARS-CoV-2 infection and meeting all criteria, will be recruited to receive either BEJO Red Ginger or placebo in addition to standard of care (SOC) in a 1:1 ratio.

Patients with a diagnosis of COVID-19 and, due to mild symptoms, hospitalized, will be randomized to take a sachet of syrups containing 15 ml of BEJO Red Ginger, 3 times a day: 1 sachet after breakfast, 1 sachet after lunch, and 1 sachet after dinner, as add-on to the SOC, with 2 hours of incubation of SOC. The treatment will last for 14 days or until patients to be declared as cured. The treated patients will be compared with an equal group treated with placebo and SOC. Recovery time, symptoms, and objective (inflammatory) parameters (see detailed description) will be analyzed as outcomes. The goal of this study is to evaluate the role of BEJO Red Ginger in preventing progression of COVID-19 and accelerating healing process in patients.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 50 years, both sexes.
* Newly diagnosed adult patients with positive SARS-COV-2 by Real Time-PCR, using an appropriate sample such as nasopharyngeal, oropharyngeal, or nasal swab (within 3 days prior to study enrolment).
* Patients diagnosed with mild clinical manifestations, according to the Management of COVID-19 patients issued by The Indonesian Society of Respirology (Kepmenkes HK.0107/MENKES/5671/2021). Mild symptoms including fever, cough, shortness of breath, myalgia, sore throat, anosmia, diarrhea, nauseous and other symptoms.
* Hospitalized patients.
* Subject must have provided written informed consent which includes signing the institutional review board approved consent form prior to participating.

Exclusion Criteria:

* Asymptomatic COVID-19 patients
* Presence of any of the following abnormal laboratory values:

  * Elevation in serum glutamic oxaloacetic transaminase (SGOT) and/ or serum glutamic pyruvic transaminase (SGPT) of greater than 5 times the upper limit of normal (SGOT normal value 34 - 45 UI; SGPT normal value 31 - 35 UI)
  * Elevation in urea and creatinine blood levels of greater than the upper limit of normal (Urea normal value 10 - 44 mg/dL; creatinine normal value 0.4 - 1.4 mg/dL)
* Patients with severe pneumonia.
* Patients with serious co-morbidity, including: coronary heart diseases, congestive heart failure, arrhythmia, liver diseases, hypertension, diabetes mellitus (DM) type 1 and 2, glucocorticoid-induced DM, geriatric syndromes, autoimmune diseases, severe renal impairment, myocardial infarction, chronic obstructive pulmonary diseases (including asthma, tuberculosis) , and malignancies. The medical history was determined by from the statement of prospective subjects.
* Patients with ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI), proved by an electrocardiogram (ECG) result.
* Be pregnant, confirmed with a negative pregnancy test.
* Lactating and breast feeding.
* Has consumed, or consuming herbal medicines or supplements other than SOC for COVID-10 in RSDC Wisma Atlet.
* Patient who has allergies to the test product.
* Active participation in other drug clinical trials.

Primary outcomes:
measure: Nucleic acid conversion time from randomization to the date of negative RT-PCR test result on the determined examinations.
timeFrame: from randomization to day 14 or until hospital discharge
Secondary outcomes:
measure: Clinical improvement; from initiation of study treatment (active or placebo) and daily anamnesis.
timeFrame: from randomization to day 14 or until hospital discharge
measure: Assessment of IL-6 level
timeFrame: from randomization to day 14 or until hospital discharge
measure: Assessment of TNF-alfa level
timeFrame: from randomization to day 14 or until hospital discharge
Other outcomes:
measure: Incidence of adverse events (AEs) and clinical worsening in patients hospitalized with COVID-19 should be referred to referral hospital.
timeFrame: from randomization to day 14 or until hospital discharge
measure: Biochemical assessment of serum SGOT level
timeFrame: from randomization to day 14 or until hospital discharge
measure: Biochemical assessment of serum SGPT level
timeFrame: from randomization to day 14 or until hospital discharge
measure: Biochemical assessment of urea level
timeFrame: from randomization to day 14 or until hospital discharge
measure: Biochemical assessment of creatinine level
timeFrame: from randomization to day 14 or until hospital discharge
measure: Peripheral blood smear test
timeFrame: from randomization to day 14 or until hospital discharge
Locations:
city: Jakarta
country: Indonesia
facility: RSDC Wisma Atlet Kemayoran
Study officials:
affiliation: Persahabatan General Hospital
name: Erlang Samoedro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Research and Innovation Agency of Indonesia
name: Intan Satwika Putri, S.T, M.T
role: STUDY_DIRECTOR
affiliation: RSDC Wisma Atlet
name: Putro Setyobudyo Muhammad, MD
role: STUDY_CHAIR
References: