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Tawa-tawa Clinical Trial in COVID-19

PHRR210412-003475

Unspecified

2020-CT0566

A randomized controlled clinical trial on the efficacy and safety of Tawa-tawa (Euphorbia hirta L.) extract as an adjunctive treatment for mild to moderate COVID-19 patients

This study will employ an interventional, randomized controlled phase II dose-finding study design to evaluate the effects of standardized aqueous spray-dried extract of E. hirta (U4bext®) on the progression of and symptom resolution from COVID-19 versus current guidelines for standard of care. Different doses of U4bext® will be orally administered daily for 7 to 10 days upon enrollment in the study. Parallel dose comparisons corresponding to dosages of 650mg and 975mg thrice daily of the extract in commercial form will be done to assess the optimal dosage recommendations. This trial will be conducted at the Quezon Institute Mild COVID-19 Isolation Facility (QI-MCIF, Quezon City), Quezon Institute Modular Hospital (QI-MH, Quezon City), Corazon Locsin Montelibano Memorial Regional Hospital (CLMMRH, Bacolod City), and in quarantine facilities and referral hospitals in Negros Occidental province, namely Cadiz District Hospital (CDH), Valladolid District Hospital (VDH), EB Magalona Healing Facility (EBMHF), Silay Healing Facility (SHF) and Cadiz Healing Facility (CHF). This study will recruit laboratory-confirmed mild or moderate COVID-19 patients aged 18 to 59 years, admitted at the study sites, from February 1, 2021 to July 31, 2021. 

Regime Classification Priority
2017 - 2022 Research to enhance and extend healthy lives Access to essential medical products, vaccines and technologies
Start Date Duration in Months Target Completion Date Actual Completion Date
2021-02-01 6 2021-08-01 2021-07-31

Ongoing

Institution Classification Region LTO #
University of the Philippines - Visayas Public Higher Education Institution - State Universities and Colleges Region VI
Institution Classification Region LTO #
University of the Philippines - Manila, College of Medicine Public Higher Education Institution - State Universities and Colleges NCR
Corazon Locsin Montelibano Memorial Regional Hospital Government Region VI
Quezon Institute Government NCR
Institution Region
Philippine Council for Health Research and Development, Department of Science and Technology NCR
Herbanext Laboratories, Inc. Region VI
Name E-Mail Institution and Institution Address
PHILIP IAN PADILLA PPPADILLA@UPV.EDU.PH UNIVERSITY OF THE PHILIPPINES VISAYAS, MIAGAO, ILOILO
Name E-Mail Institution and Institution Address
PHILIP IAN PADILLA PPPADILLA@UPV.EDU.PH UNIVERSITY OF THE PHILIPPINES VISAYAS, MIAGAO, ILOILO
Name Expertise Affiliation
John Carlo M. Malabad, MD, PhD MOLECULAR MEDICINE University of the Philippines - Manila, College of Medicine
Jubert P. Benedicto, MD PULMONOLOGY, CRITICAL CARE University of the Philippines - Manila, College of Medicine
Ma. Luz Vicenta Guanzon, MD ENDOCRINOLOGY, INTERNAL MEDICINE Corazon Locsin Montelibano Memorial Regional Hospital
Paulyn Jean R. Ubial, MD, MPH PUBLIC HEALTH Quezon Institute
Project Location Institutional Ethics Review Board
University of the Philippines - Manila, College of Medicine N/A
University of the Philippines - Manila, College of Medicine N/A
Corazon Locsin Montelibano Memorial Regional Hospital CLMMRH - RERC
Quezon Institute Quezon Institute Ethics Review Board

COVID-19

The primary outcome for this trial is clinical improvement, defined as at least 2 categories of improvement from baseline in the 7-category Ordinal Scale of patient status

The secondary outcomes to be evaluated are as follows:

  1. Time to Improvement of at least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status
  2. Time to Clinical Failure [From first dose to time of death, mechanical ventilation, ICU admission, or study withdrawal]
  3. Time to resolution of symptoms
  4. Time to normalization of biochemical/haematological parameters
  5. Time to Hospital Discharge
  6. Duration of Time on Supplemental Oxygen
  7. Percentage of Participants with Adverse Events
  8. Time to Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) Virus Negativity
  9. Proportion of Participants with Post-Treatment Infection

Recruiting

Clinical Trial

Unspecified

20200908072628

2021-03-23

0000-00-00

270

270

Unspecified

2021-02-01

Inclusion Criteria

  1. Patients hospitalized due to COVID-19 confirmed per WHO criteria (including a positive PCR of any specimen, g., respiratory, blood, urine, stool, other bodily fluid);
  2. Patients who fulfill the mild or moderate COVID-19 case definitions by the WHO Interim Guidance on Clinical Management of COVID-19 (May 27, 2020);

 Exclusion Criteria

  1. Known allergic reactions to hirta extracts
  2. Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)
  3. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
  4. Severe or critical COVID-19 case by definition from the WHO Interim Guidance on Clinical Management of COVID-19 (May 27, 2020)
  5. Patients who are participants of other clinical trials
  6. Patients with Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 x upper limit of normal (ULN) detected within 24 hours at screening or at baseline
  7. Patients taking aspirin
  8. Patients with hypertension and diabetes mellitus
  9. Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study

Interventional

TAWA-TAWA EXTRACT

Tawa-tawa extracts (U4bext® capsules) are manufactured by Herbanext Laboratories, Inc., a cGMP-certified facility for the production of food and drugs, located in Bago City, Negros Occidental. U4bext® is a product of the DOST Tuklas Lunas R&D Program.

None

Randomized

Open Label

Unspecified

Single

N/A

Phase II

Utilization Utilization Info
No records found.
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