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Submitted by: Cecilia Nelia C. Maramba-Lazarte, MD 2020-09-29 08:28:56 Last Updated by: Principe, Jeverly Ann S 2021-01-26 18:58:08


Efficacy and Safety of Vitex negundo for MILD COVID-19 Trial (EVICT Program)

PHRR210126-002992

UPMREB 2020-339-01

2020-CT0553

2-stage, Randomized, double-blind, placebo-controlled clinical trial on the efficacy and safety of Lagundi (Vitex negundo) tablets/syrup (NIRPROMP formulation) with standard treatment compared to placebo with standard treatment in patients with mild COVID disease without comorbidities

Since the emergence of COVID-19, researchers around the world have escalated their efforts to develop vaccines and possible treatments to address the virus and the disease. Currently, a number of existing and new treatments are in different preclinical and clinical trials to determine their safety and efficacy for treating COVID-19. Discovering a drug useful for the symptomatic treatment of MILD COVID-19 would greatly help those who are suffering from the disease. If the lagundi can prevent the progression to more severe illness and help decrease mortality, then this drug can be a game-changer in the . Study Design The 1st stage, which shall be an exploratory study. Two doses of Lagundi tablet/syrup shall be assessed for efficacy and safety, High dose (1.2gm 3x/day vs. Normal Dose (600mg 3x/day) both with the standard of care in patients without comorbidities with suspected and confirmed mild COVID-19. The primary endpoint shall be the mean time to clinical recovery. The more efficacious and safe dose shall be used in stage 2. The second stage is a randomized, double-blinded, placebo-controlled, parallel clinical trial shall be conducted. This second stage of the program shall be a parallel-group, placebo-controlled, double-blinded, superiority trial with a 1:1 allocation ratio. The 1st arm the more effective dose from the first stage shall be used plus standard of care compared to placebo plus standard of care in patients with no comorbidities with suspected or confirmed mild COVID-19. The primary endpoint shall be the mean time to clinical recovery.

Regime Classification Priority
2017 - 2022 Global competitiveness and innovation in health Drug discovery and development
Start Date Duration in Months Target Completion Date Actual Completion Date
2020-09-14 5 2021-02-14 0000-00-00

Ongoing

Institution Classification Region LTO #
National Institutes of Health - University of the Philippines - Manila, Institute of Herbal Medicine Government NCR 3000001863742
Institution Classification Region LTO #
National Institutes of Health - University of the Philippines - Manila, Institute of Herbal Medicine Government NCR 3000001863742
Institution Region
Philippine Council for Health Research and Development, Department of Science and Technology NCR
National Institutes of Health - University of the Philippines - Manila, Institute of Herbal Medicine NCR
Name E-Mail Institution and Institution Address
Cecilia C. Maramba-Lazarte, MD, MScID, MScCT ccmaramba@up.edu.ph UP College of Medicine Pedro Gil St., Manila
Name E-Mail Institution and Institution Address
Cecilia C. Maramba-Lazarte, MD, MScID, MScCT ccmaramba@up.edu.ph UP College of Medicine Pedro Gil St., Manila
Name Expertise Affiliation
Cecilia Nelia C. Maramba-Lazarte, MD Pharmacology, Infectious Diseases National Institutes of Health - University of the Philippines - Manila, Institute of Herbal Medicine
Project Location Institutional Ethics Review Board
National Institutes of Health - University of the Philippines - Manila, Institute of Herbal Medicine N/A

MILD COVID-19

1.Mean clinical recovery time (hours) The clinical recovery time is defined as the time from initiation of study treatment (active or placebo) until normalization of fever, respiratory rate, and oxygen saturation, and alleviation of cough sustained for at least 72 hours. Normalization and alleviation criteria using the (1) Fever: ≤37.2 °C oral or ≤37.8°C rectal or tympanic;(2)Respiratory rate - ≤24/minute on room air; 3) Oxygen saturation - >94% on room air; (4) Cough - mild or absent on a patientreported scale (cough symptoms score ≤ 2 points).

Secondary Outcome Measures : 1. Time to CoVID-19 RT-PCR negative in the upper respiratory tract 2. Time to defervescence (in those with fever at enrolment) 3. Time to absent symptoms in days for the following (cough, cold/nasal obstruction, fatigue, body malaise, sore throat, feverishness 4. No. of patients progressing to moderate disease 5. Type, frequency and severity of adverse effects

Recruiting

  • Philippines

Clinical Trial

UPMREB 2020-339-01

20200708143628

2020-08-17

0000-00-00

280

Unspecified

Unspecified

14 Sep 2020

1. Age between 19 and 55 years based on a government-issued ID with their birthday. 2. Manifestations of signs and symptoms of Mild COVID-19 (based on the DOH criteria for mild COVID-19) 3. Can tolerate the intake of oral medications 4. Nasopharyngeal swab sampled and sent to the laboratory for RT-PCR testing or with a positive finding of infection with COVID-19 5. Modified Early Warning Score (MEWS) < 5. 6. Willingness to give written informed consent (before any study-related procedures being performed) and to be able to adhere to the study restrictions and examination schedule. Exclusion Criteria: 1. Known to be allergic to lagundi tablet or syrup 2. Patient weight is less than 40 kg; 3. Respiratory distress-RR≥30 / min on room air, or SPO2≤ 93%. 4. The clinician determines that the patient needs to be hospitalized 5. Patients who have participated in other clinical trials within one month 6. Pulmonary TB, chronic cardiovascular disease, chronic lung disease, chronic liver disease, chronic kidney disease, chronic neurologic conditions, diabetes, problems with the spleen, weakened immune systems such as HIV, AIDs or, intake of medicines such as steroids or chemotherapy, herbal medicines, and food supplements, morbid obesity (BMI>40) 7. Being pregnant or breastfeeding, or having a positive pregnancy test at the time of pre-dose inspection 8. Unwillingness or inability to follow the procedures outlined in the protocol.

Interventional

Lagundi (NIRPROMP Formulationtablet or syrup

Unspecified

None

Randomized

Double Blind

The pharmacist will prepare the randomization lists. Each treatment pack of tablets or syrup shall be labeled with an accession number. The Lagundi tablet or syrup will be randomly assigned to the participants. The physician who will be assessing and monitoring the patients will be unaware of their treatment assignment. Lagundi Tablets and syrups shall have similar packaging and labelling as the placebo. Placebo tablets and syrup look similar to the lagundi tablet and syrup.

Parallel

Since the emergence of COVID-19, researchers around the world have escalated their efforts to develop vaccines and possible treatments to address the virus and the disease. Currently, several existing and new treatments are in different preclinical and clinical trials to determine their safety and efficacy for treating COVID-19. Although MILD COVID Disease results in recovery in 80% of cases, experiencing the disease is very difficult because the spectrum of symptoms may be minor to downright unpleasant and traumatic for the patients. Although the patients do not need to be hospitalized, the symptoms may be uncomfortable and incapacitated during the time of illness. Having a medication that could relieve symptoms of cough, sore throat, and difficulty of breathing, which are often described by some patients as unbearable, would be most helpful to make the patients more comfortable during the illness. Also, decreasing the time to recovery would assist the patients to get back to their healthy lives much faster. Additionally, if Lagundi (NIRPROMP Formulation) is found to be efficacious in preventing mild COVID-19 patients from progressing to moderate or severe disease, lagundi can be a game-changer in the management of Mild COVID-19.

Phase III

Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
Posters
Others
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