(CMC) — The Trinidad-based Caribbean Public Health Agency (CARPHA) Tuesday urged regional countries to only use the medicine, ivermectin, under the conditions of well-regulated clinical trials for the coronavirus (COVID-19) pandemic or for approved indications.
“CARPHA does not support the use of ivermectin outside of appropriately designed, well-regulated clinical trials for the treatment of COVID-19.
“Further CARPHA maintains that large randomised controlled clinical trials, with robust study design, meaningful endpoints, and significant results are essential to inform public health decision-making about treatments for COVID-19, as these are designed to rule out findings of benefits and risks that may appear due to chance,” CARPHA said in the statement.
In its statement, CARPHA said its advice to regional countries is a result of the limited evidence available to assure a favourable benefit-risk balance when used in treating patients with COVID-19. It said this is also reflected by the recommendations of the global health authority, World Health Organization (WHO).
In its “Therapeutics and COVID-19: Living Guideline”, March 31, 2021, the WHO Guideline Development Group explained that “the effects of ivermectin on mortality, mechanical ventilation, hospital admission, duration of hospitalisation and viral clearance remain uncertain because of very low certainty of evidence addressing each of these outcomes”.
The WHO, in its press release on ivermectin, also noted that the current evidence is of “very low certainty,” due to the small sizes and methodological limitations of available trial data.
CARPHA executive director, Dr Joy St John, said in light of this, “I am aware that some countries have already begun to use ivermectin in the treatment of COVID-19, and others may be considering using the drug as a possible treatment.”
“However, CARPHA is urging our member states to heed the current advice of the WHO, regardless of disease severity or duration of symptoms,” she added.
CARPHA also noted that the Pan American Health Organization (PAHO) in its “Living Update of COVID-19 Therapeutic Options Rapid Review” of May 6, this year, noted that after review of 28 clinical trials “new evidence from randomised clinical trials was evaluated, however, there is no change to the assessment that the medicine does not significantly reduce mortality and probably does not improve time to symptom resolution”.
CARPHA said also recognising the need for further research, the US National Institutes of Health (NIH) stated “results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin in the treatment of COVID-19”.
According to the NIH, ivermectin is an antiparasitic drug that is used to treat several neglected tropical diseases, including scabies. Furthermore, ivermectin is not approved by the US Food and Drug Administration (FDA) for the treatment of any viral infection.