The broad-spectrum antiviral drug remdesivir was not approved to be clinically beneficial as it showed unfavorable and discouraging outcomes in the previous clinical trial on patients with COVID-19. Therefore, the researchers are now conducting a new trial of remdesivir in combination with another cytokine known as Interferon Beta a-1 to check whether the combination will show any clinical efficacy and safety for the patients of COVID-19, says a recent report published by the National Institutes of Health (NIH).
News: NIH clinical trial testing remdesivir plus interferon beta-1a for COVID-19 treatment begins https://t.co/r86CtVdvNQ
— NIH (@NIH) August 6, 2020
The coronavirus has been on a rampage throughout the world after becoming a pandemic in less than three months. The researchers around the globe are toiling to develop a vaccine on a massive level to provide the whole world. But currently, there is no clear evidence that any pharmaceutical drug with proven clinical efficacy has been developed that has the potential to fight against the deadly virus.
Therefore, the present study will aim to collect 1,000 hospitalized patients suffering from the deadly coronavirus. The current study will be known as ACTT-3 which means Adaptive COVID-19 Treatment Trial 3.
Formation of ACTT, ACTT-2 and ACTT-3
ACTT was started on 21 February 2020 at the University of Nebraska Medical Center (UNMC) in Omaha, to check the clinical efficacy and effectiveness of Remdesivir that can be defined as an antiviral drug that interferes with viral replication. It is effective against early dangerous pathogens including Ebola Nipah, Marburg, and MERS-CoV.
Later, the ACTT-2 has started on 8 May 2020 to examine if adding an anti-inflammatory agent to the remdesivir regimen can provide additional benefit for patients, including improving mortality outcomes.
— M (@bio_clouseau) May 8, 2020
So, ACTT-3 is now based on a combination of remdesivir with a cytokine from the interferon family known as Interferon Beta a-1 which is a class of medication called immunomodulators. The medication is manufactured by Merck KGaA, Darmstadt, Germany, and
}is mainly used to treat a chronic illness that affects the brain and spinal cord known as ‘multiple sclerosis’ (MS). The medication is approved by the United States and currently being used in 90 different countries that result in decreased inflammation and prevent nerve damage that causes MS as it has both antiviral and anti-inflammatory properties.
#COVID19 NEWS: A @NIAIDNews clinical trial testing #remdesivir plus subcutaneous #InterferonBeta1a for COVID-19 treatment has begun. The study is called the Adaptive COVID-19 Treatment Trial 3 (ACTT 3). https://t.co/VtgQNNYX5h #SARSCoV2 #NIH pic.twitter.com/1tU9jVgc2d
— NIAID News (@NIAIDNews) August 5, 2020
Previously, it has been found that interferon-beta a-1 is potentially strong in reversing the infection caused by COVID-19 and two other life-threatening viruses including SARS-CoV and MERS-CoV. Therefore, the research team has now designed a randomized, controlled clinical trial aimed to used interferon-beta a-1 with anti-viral remdesivir that can reverse the infection from hospitalized patients with COVID-19 that has caused huge disaster by taking nearly 718,000 lives. The virus has infected more than 19 million people around the globe.
While the virus has made huge destruction throughout the world, more than 11.5 million people have successfully fought against the coronavirus and recovered, according to the data excluded from two main resources including Johns Hopkins University (JHU) live update about coronavirus and Worldometer.
The team will collect 1,000 confirmed cases of COVID-19 from 100 different sites of the US as well as from outside the US. By following the standard clinical research protocols, the team will extract those in-patients who will provide informed consent and also the laboratory evidence of having COVID-19 with lung involvement, including a need for supplemental oxygen, abnormal chest X-rays, or illness requiring mechanical ventilation.
Later, the study participants will be divided into two groups. The first group will be the combination group whereas the second group will be the placebo.
Combination Group Treatment: The team will administer subcutaneous interferon beta-1a with a combination of remdesivir or remdesivir alone. The trial will be blinded as both of the participants and team will not be aware of which treatment is given to which participant.
Those participants who received a combination treatment will receive four doses of 44 micrograms subcutaneous injection of interferon-beta a-1 per day and will receive every four doses until they remain admitted to the hospital.
Placebo Group Treatment: Patients from placebo will receive a matching placebo subcutaneous injection every other day for a total of four doses during hospitalization.
The main area of assessment will be the ‘Time’. The team will measure the recovery period of both groups from the baseline to the hospital discharge for 29 days.
The investigators will use an ordinal eight-point scale to make a comparison on day 15 that will involve a range of recovery till death as well as mortality alone of patients.
An independent data and safety monitoring board (DSMB) will monitor ongoing results to ensure patient well-being and safety as well as study integrity. Preliminary results are expected in the fall of 2020.
The current clinical trial is sponsored by The National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH.