Andrographolide as a medical tool for reduction of hospitalization in mild or asymptomatic COVID-19 patients: a randomized double-blind placebo controlled trial

Phase 3

• Conditions: Andrographolide for COVID-19 patients with mild or no symptom admitted to hospitel or field hospital.; Andrographolide; COVID-19; Hospitel; Field Hospital

• Registration Number: TCTR20210514003
• Lead Sponsor: Department of Thai Traditional and Alternative Medicine, Ministry of Public Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-14
• Study Completion: 2021-10-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1)Thai participant aged 18-60 years
2)PCR confirmed COVID-19 patient with normal chest X-ray
3)No silent hypoxia by 1-minute sit to stand test (4% or more oxygen saturation reduction after test compared to before test will be considered presence of silent hypoxia) (Key, 2020)
4)Communicable by Thai language
5)Informed consented for participation

Exclusion Criteria

1)Presence of sign or symptoms of pneumonia
2)Receiving at least one anti-viral therapy including Favipiravir, Remdesivir, Lopinavir, Ritonavir, Interferon (B1a), Chloroquine or hydroxychloroquine
3)History of andrographolide allergy
4)Pregnant or lactating women, or plan for pregnancy
5)Participated in other research related to COVID-19 treatment
6)Received andrographolide within 5 day before participation
7)Current smoker with 10 or more cigarettes per day
8)On anti-hypertensive medication
9)History of heart disease, rheumatic heart disease, or acute poststreptococcal glomerulonephritis
10)On anti-platelet or anti-coagulant medication i.e. clopidogrel, warfarin, aspirin.
If participants took only low dose aspirin (not more than 81 mg per day) and no sign and symptom of abnormal coagulation, they will not be excluded.
11)Physician concerns for risk or harm from patient's participation.
Risk factor for severe disease progression including, but not limited to
a.Chornic obstructive pulmonary disease, active TB, pneumonia, or asthma
b.Chronic kidney disease, acute kidney injury, end-stage renal disease
c.Cardiovascular disease or congenital heart disease
d.Stroke
e.Uncontrolled diabetes mellitus
f.Obesity (BMI > 35 kg/sq.m)
g.Cirrhosis
h.Immunocompromised host
i.Lymphocyte less than 1,000 cell/m3

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hospitalization rate during 14 days (if any) Medical record

Secondary Outcome Measures

Name	Time	Method
Duration before hospitalization during 14 days (if any) Medical record,COVID-19 symptoms baseline, once per day for 14 days Patient report,Adverse event during 14 days (if any) Patient report,Silent hypoxia baseline, once per day for 14 days 1 minute sit to stand test,Chest X-ray only when silent hypoxia present Clinical diagnosis,Vital signs baseline/ 5 minute intervals during 14 days (if available) manual/automated by smart wristband (if available),Electrocardiogram baseline and 5 minute intervals during 14 days (if available) automated by smart wristband (if available)