COVID-19 Treatments

COVID-19 Treatments

The U.S. Food and Drug Administration (FDA) has granted emergency use authorizations (EUA) for specific treatments for patients infected with the SARS-CoV-2 virus and for people hospitalized with COVID-19.

Molnupiravir (MK-4482/EIDD-2801) is an oral antiviral medication initially developed to treat influenza. The EMA has started a rolling review of molnupiravir (Lagevrio).

CytoDyn's Leronlimab is intended to serve as a therapy for patients who experience respiratory illness due to COVID-19. The U.S. FDA previously granted CytoDyn Fast Track designation to explore using leronlimab to treat HIV and metastatic cancer.

The COVID-19 Treatment Guidelines Panel published updated Recommendations for Actemra (Tocilizumab) on March 5, 2021, an anti-inflammatory drug used to treat rheumatoid arthritis, has been reported to improve severely ill COVID-19 patients' outcomes.

AstraZeneca's AZD7442 long-acting antibody combination (LAAB) is launching late-stage clinical studies in various countries. Combining two LAABs is also designed to reduce the risk of resistance developed by the SARS-CoV-2 virus.

On December 23, 2020, Merck announced it has entered into an agreement with the U.S. Government to support the development, manufacture, and initial distribution of an investigational biological therapeutic (CD24Fc, to be named MK-7110) upon approval or Emergency Use Authorization from the U.S. FDA. Merck acquired MK-7110 through the acquisition of New Jersey-based OncoImmune.

Olumiant (baricitinib), an oral JAK1/JAK2 inhibitor, is evaluated in a phase 3 study in hospitalized adults with COVID-19.

Aviptadil (RLF-100) is a formulation of synthetic human Vasoactive Intestinal Peptide, which targets the VPAC1 receptor of the ATII cell and protects that cell against all manner of injuries, including smoke inhalation, exposure to stomach acid, and exposure to infectious agents. The U.S. FDA granted Expanded Access Protocol to RLF-100 (Aviptadil) for Respiratory Failure in COVID-19.

Tradipitant may accelerate clinical improvement in hospitalized COVID-19 pneumonia patients reported in a phase 3 study. Tradipitant is an experimental drug that is a neurokinin one antagonist. It works by blocking substance P, a small signaling molecule.

NRx Pharmaceuticals announced on June 1, 2021; it had applied with U.S. FDA requesting a EUA for ZYESAMI™ (Aviptadil-acetate) to treat Critically Ill COVID-19 patients suffering from respiratory failure.

Roche and Atea's AT-527 has demonstrated clinical safety/tolerability and potent antiviral efficacy in patients with HCV infection, as well as a favorable human pharmacokinetic profile, with potent in vitro activity against human coronaviruses.

Pfizer Inc. is evaluating an investigational, novel oral antiviral clinical candidate PF-07321332. This SARS-CoV2-3CL protease inhibitor has demonstrated potent in vitro antiviral activity against SARS-CoV-2 and activity against other coronaviruses, suggesting potential for use in the treatment of COVID-19 as well as potential use to address future coronavirus threats.

COVID-19 Treatment News

October 27, 2021 - The Medicines Patent Pool and Merck announced the signing of a voluntary licensing agreement to facilitate affordable global access for molnupiravir, an investigational oral COVID-19 antiviral medicine for the treatment of mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization.

October 27, 2021 - RELIEF THERAPEUTICS announced that its wholly-owned subsidiary, APR Applied Pharma Research SA reported positive interim results from its clinical trial of nasal spray Sentinox in SARS-CoV-2 infected patients, confirming its safety and tolerability. Relief also reported that data from the study suggest that Sentinox could effectively reduce the SARS-CoV-2 viral load at the level of the nasal mucosa.

October 27, 2021 - The Lancet published a study from Brazil - Effect of early treatment with fluvoxamine on the risk of emergency care and hospitalization among patients with COVID-19: the TOGETHER randomized, platform clinical trial. Treatment with fluvoxamine (100 mg twice daily for ten days) among high-risk outpatients with early diagnosed COVID-19 reduced the need for hospitalization, defined as retention in a COVID-19 emergency setting or transfer to a tertiary hospital. Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) approved by the Food and Drug Administration (FDA) for the treatment of obsessive-compulsive disorder and is used for other conditions, including depression. Fluvoxamine is not FDA-approved for the treatment of any infection.

October 11, 2021 - Positive high-level results from the TACKLE Phase III COVID-19 treatment trial showed AstraZeneca's AZD7442, a long-acting antibody combination, achieved a statistically significant reduction in severe COVID-19 or death compared to placebo in non-hospitalized patients with mild-to-moderate symptomatic COVID-19.

Note: This content was reviewed by health care professionals, such as Dr. Robert Carlson.