The condition of patients with mild coronavirus disease (COVID-19) who were involved in the country’s lagundi clinical trials has “not progressed” to moderate or severe cases, and no adverse effects have been observed in the participants, based on the study’s initial data analysis.
This was disclosed by DOST Secretary Fortunato “Boy” T. de la Peña during his weekly report on Friday, June 25.
He said the project team, headed by Dr. Cecilia Nelia C. Maramba-Lazarte of the University of the Philippines (UP) Manila-National Institute of Health (UP-NIH) “is still in the middle of data analysis for Stage 2 of the project.”
The lagundi clinical trials have two stages—the dose-finding and safety study, and placebo-controlled clinical trial.
The project, which started on July 13, 2020, seeks to look into the efficacy and safety of lagundi tablets or syrup as a COVID-19 therapeutic or supplement.
De la Peña said the screening and recruitment of participants for Stage 1 and Stage 2 have already been completed.
The project has enrolled a total of 278 participants from seven quarantine facilities, he said.
He said among the preliminary results obtained from the analysis were the following:
-No patient progressed to moderate or severe, nor were there any deaths for both the lagundi and placebo group.
-There is a significant difference between anosmia score over time via linear regression and Repeated Measures Analysis of Variance (RMANOVA) between lagundi and placebo with lagundi having lower scores (the lower scores means less symptoms and improvement).
-There is a significant difference between the total symptom score over time via linear regression and RMANOVA between lagundi and placebo also favoring lagundi.
-There is no significant difference in time to recovery between lagundi and placebo overall and for each symptom, for example, in terms of safety, no serious adverse events were reported.
“Analysis for other outcomes- such as RT-PCR (reverse transcription-polymerase chain reaction) and viral load are forthcoming,” de la Peña said.
In late March this year, Lazarte said the lagundi clinical trials are expected to be completed soon.
In July 2020, it was announced that the clinical trials for lagundi were approved by DOST-Philippine Council for Health Research and Development (PCHRD). In April last year, the DOST started looking into the effectiveness of certain herbal medicines against COVID-19.
Lagundi is widely used as a cough remedy.
The Food and Drug Administration (FDA) approved the clinical trials for lagundi as a supplemental treatment against COVID-19 in August 2020.