Melissa Rosales
Director General
RM Pharma
/
Expert Contributor

Clinical Trials of Coronavirus Drugs: Antibodies Against COVID-19

By Melissa Rosales | Tue, 10/06/2020 - 09:00

Research teams and pharmaceutical companies across the world are racing to develop vaccines and effective treatments against COVID 19. One of the research lines in clinical trials is using antibody treatments, which are made to act like immune cells , and could both prevent and treat the disease.

In December 2019, a pneumonia of unknown cause was identified in clusters of patients in Wuhan City, China. A novel enveloped RNA betacoronavirus – severe acute respiratory síndrome coronavirus 2 (SARS-CoV-2) – was identified in these patients, and the viral infection was later designated coronavirus disease 2019 (COVID-19) by the World Health Organization. As of June 2020, more than 7.6 million confirmed cases of COVID-19 have been reported globally (WHO, 2020a). This rapidly-spreading, worldwide outbreak prompted the WHO to declare COVID-19 a pandemic and public health emergency of international concern on March 11, 2020.

Many therapeutic agents have been studied in the context of other coronaviruses (SARS-CoV and MERS-CoV), including corticosteroids, type 1 interferons, convalescent plasma, ribavirin, lopinavir/ritonavir, proteases and agents targeting viral entry proteins, with generally inconsistent findings of efficacy (Sanders, 2020). Several of these therapies, as well as a number of other potential treatments and vaccines, are under investigation for the treatment of SARS-CoV-2. On May 1, 2020, remdesivir received Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for the treatment of hospitalized patients with COVID-19 (FDA, 2020). 

Currently, however, there is no approved prophylaxis for COVID-19 nor for patients who are infected with SARS-CoV-2 but are asymptomatic. Given the speed at which this outbreak has spread and how it has impacted almost every community globally, there is an urgent need to develop safe and efficacious interventions to slow the spread of the SARS-CoV-2 virus and decrease adverse outcomes associated with symptomatic disease.

Antibodies are Y-shaped proteins produced by the human body as part of a normal immune response to foreign molecules. Antibodies then go to work to defend you against the harmful invader.

Regeneron Pharmaceuticals is currently developing fully human, neutralizing monoclonal antibodies directed against the S protein of SARS-CoV-2, for the treatment and prevention of SARS-CoV-2 infection. REGN10933 and REGN10987 are fully human, IgG1 monoclonal antibodies that bind to distinct regions of the receptor binding domain of the SARS-CoV-2 S protein and block interaction with ACE2RM . 

Clinical trials are very important for discovering new treatments as well as new ways to detect, diagnose and reduce the chance of developing the disease. It is a way to learn how to improve medical treatments an provide care.

Regeneron will be conducting clinical trials using these monoclonal antibodies in Mexico, which it is expected to initiate in fall 2020. RM Pharma Specialists has been selected as the clinical research site to conduct two clinical trials:

  1.  R10933-10987-COV-2067 Master Protocol Assessing the safety, tolerability, and efficacy of anti-spike (S) SARS-CoV-2 monoclonal antibodies for the treatment of ambulatory patients with COVID-19 
  2. R10933-10987-COV-2069 A Phase 3, randomized, double-blind, placebo-controlled study assessing the efficacy and safety of anti-spike SARS-CoV-2 monoclonal antibodies in preventing SARS-Cov-2 infection in household contacts of individuals infected with SARS-CoV-2


Both studies are registered with www.clinicaltrial.gov where details such as inclusion/exclusion criteria, investigational drug, locations, etc., can be reviewed. 

Having this opportunity to participate and be part of the hunt for a treatment or vaccine for this unprecedented pandemic, RM Pharma through its principal investigator and clinical staff needs to focus on proactive planning subject recruitment and determine the factors that encourage patients to enter studies. In this case, whole families can receive the benefits of participation in the trials, due to protocol 2067, which is for patients with a COVID-positive test and mild symptoms, and protocol 2069 for their household contacts who are not yet positive but have been exposed to the virus. 

Achieving enrollment milestones is a determining factor in clinical research and an important objective for RM Pharma is to establish an active partnership between the medical community and local laboratories to detect COVID-positive cases and to refer these people to the trials. 

The new challenge for us is the protection of medical staff who will face the disease while working in these trials. It is crucial to follow COVID-19 protocols inside the site: use personal protective equipment (PPE), receive comprehensive training of how to put on and take off the PPE, maintenance and disposal of PPE and garbage disposal. 

The plan is to recruit and conduct COVID 19 trials one week every month with personnel involved in the studies quarantined after this. Other ongoing studies will be conducted during the other three weeks so as not to expose other patients and personnel. After all, healthcare professionals are the most valuable resources in the fight against the global pandemic.

Sincerely, I hope our experience will be of help in finding a treatment for this disease that has changed everything. Nevertheless, the responses to the pandemic have also introduced innovations that will advance the conduct of clinical research and at least in Mexico, our Ministry of Health ( COFEPRIS) has accelerated procedures for evaluating the authorization of clinical trials related to COVID-19. Hopefully, this also translates into faster authorization for all clinical trials to make us more competitive as a country. 

Photo by:   Melissa Rosales