WHO Covid-19 Solidarity Trial’s Next Phase Excludes Ivermectin

By Kanmani Batumalai |

Principal investigator Dr Chow Ting Soo says the World Health Organization’s (WHO) Solidarity Plus working committee instead plans to test repurposed medication like anti-malaria drug artesunate, as well as anti-inflammatory drugs like imatinib and infliximab, as potential Covid-19 treatments.

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KUALA LUMPUR, July 29 — Ivermectin, an antiparasitic drug, will not be included in the Solidarity Plus study, the next phase of the World Health Organization’s (WHO) global Solidarity Trial testing potential Covid-19 treatments.

Penang Hospital infectious disease consultant Dr Chow Ting Soo — who is one of the nine principal investigators in Malaysia’s arm of the WHO Solidarity Trial — said that WHO’s Solidarity Plus working committee plans to test three anti-inflammatory medications instead in the next phase of the WHO trial: an intravenous form of antimalarial drug artesunate, kinase inhibitor imatinib, and infliximab (a monoclonal antibody) — which has been described as “fairly promising drugs” by the WHO.

“It is actually a baby step right now. None of the countries have started because we are in the stage of getting approval,” Dr Chow said during a webinar organised by the Institute of Clinical Research (ICR) last Wednesday on “Covid-19 Updates in Palliative Care and Malaysia’s experience in WHO’s Covid-19 Solidarity Trial”.

“The development group is not thinking or getting ivermectin on to the board.”

The Solidarity Trial launched by WHO — of which Malaysia is one of the participating countries — is testing the effectiveness of several drugs on Covid-19 in terms of reducing mortality, the need for assisted ventilation, and duration of hospital stay.

“The issue is to identify a quick and fast way to identify effective treatment for Covid-19,” said Dr Chow.

“This Covid-19 pandemic started since last year, January. As up till now, today, there is not even one single agent that can be actually identified to be effectively shown to treat Covid-19, as far as we are concerned right now.”

The first phase of the WHO’s Solidarity trial included drugs like hydroxychloroquine, lopinavir, ritonavir, remdesivir, and interferon.

According to Dr Chow, more than 300 hospitals from 30 countries actively participated in the WHO study, the largest international randomised trials for Covid-19 treatments.

Hospitalised Covid-19 patients aged 18 and above were included in the WHO trial in Malaysia after getting their consent. These patients will not be given any of the drugs used in the study if they are anticipated to transfer from one hospital to another within 72 hours.

A total of 217 Covid-19 patients in Malaysia took part in the clinical trial. The Malaysian arm of the WHO Solidarity Trial, which was facilitated by the Institute of Clinical Research (ICR), involved nine major hospitals, nine principal investigators plus Ministry of Health (MOH) representative Dr Suresh Kumar, and 62 co-investigators nationwide.

The nine hospitals are Kuala Lumpur Hospital, Sungai Buloh Hospital, Penang Hospital, Melaka Hospital, Sultanah Bahiyah Hospital in Kedah, Tuanku Fauziah Hospital in Perlis, Sarawak General Hospital, Tengku Ampuan Afzan Hospital in Pahang, and Queen Elizabeth Hospital in Sabah.

The patients in the WHO trial in Malaysia consisted of various stages of Covid-19 disease — from mild to moderate and severe, except those who are critically ill whom clinicians think will not survive in the next 72 hours.

“It is actually a very special kind of design for the trial. It is unique because it’s an adaptive trial,” said Dr Chow.

She added that when any of the drugs used in the trial don’t seem promising, they can be dropped from the treatment procedure. She also mentioned that the standard of care at the time was used as controls in the trial.

Antimalarial drug hydroxychloroquine and antiretroviral drug lopinavir-ritonavir (brand name Kaletra) were discontinued as Covid-19 treatment on June 20 and July 14 last year respectively in Malaysia.

“It is actually the committee that realises that interim analysis shows futility towards further development for these two drugs because it didn’t show any positive outcomes in prevention [of] death or prevention [of needing] mechanical ventilator.

“Interferon was dropped on October 16, 2020. So in the end, we were actually left with remdesivir versus standard of care,” said Dr Chow.

The findings of the WHO Solidarity trial published in the New England Journal of Medicine on February 11 this year revealed that antiviral drug remdesivir, hydroxychloroquine, lopinavir, and interferon treatment regimes had little or no effect on hospitalised patients with Covid-19.

According to the study, the main outcomes of mortality, initiation of ventilation, and hospitalisation duration were not definitively reduced by any trial drug, either overall or in any particular subgroup.

“Now we know that hydroxychloroquine, interferon, Kaletra and even remdesivir may not show any difference in the mortality, prevention of the mechanical ventilation days, and also hospitalisation days,” Dr Chow added.

Malaysia’s MOH announced on June 5 a separate multi-centre open-label randomised controlled trial to study the efficacy of ivermectin treatment on high-risk Covid-19 patients in the country. This study is expected to be completed by September this year.

Last Tuesday in Parliament, several Pakatan Harapan MPs — including Sungai Buloh MP R. Sivarasa, Kota Raja MP and former defence minister Mohamad Sabu, Shah Alam MP and former Federal Territories Minister Khalid Samad — touted the use of ivermectin to treat Covid-19 despite the lack of clinical evidence. The United States’ Food and Drug Administration (FDA) does not recommend using ivermectin to treat or prevent Covid-19.

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