Universities Launches Clinical Trial to Assess Antiviral Drug for COVID-19

NIH-sponsored trial will study whether remdesivir, an investigational antiviral drug, may be a safe and effective agent against the novel coronavirus that causes COVID-19. Photo by David Paul Morris Bloomberg Via Getty Images

Physician-scientists at four University of California Health medical centers — UC San Diego Health, UC San Francisco, UC Irvine Health and UC Davis Health — have begun recruiting participants for a Phase II clinical trial to investigate the safety and efficacy of treating adult patients with COVID-19 with remdesivir, an antiviral drug that has shown activity in animal models and human clinical trials of SARS-CoV, MERS-CoV, Ebola, Marburg and other viruses.

Remdesivir is not approved by the U.S. Food and Drug Administration for treatment of any infection, but is undergoing clinical trials for treatment of multiple viral diseases, including COVID-19 (SARS-CoV-2) infections.

The multicenter trial will be randomized, double-blind and placebo-controlled, with the capacity to enroll in up to 75 sites globally. The UC trial will begin with a small cohort of participants. All must be hospitalized patients with diagnosed COVID-19. All must be patients of UC San Diego Health or other participating UC Health systems.

Developed by Gilead Sciences, remdesivir belongs to a class of antiviral drugs that inhibit RNA-dependent RNA polymerase, an enzyme necessary for some RNA viruses like SARS-CoV-2 to replicate. Thus, inhibiting the enzyme may prevent viral replication in infected cells. The most commonly used antiviral drug in this class of drugs is acyclovir, used for the treatment of herpes simplex virus, chickenpox and shingles.

The study will consist of a series of two-arm comparisons between different therapeutic agents and a placebo, with interim monitoring to introduce new arms as needed and to allow for early stoppage if any agents prove ineffective or unsafe.

“Due to the evolving, fluid nature of this research and what we’re learning daily about the virus and about improving treatment, the trial is designed to be adaptive, to shift investigation to the most promising avenues,” said co-principal investigator Constance Benson, MD, professor of medicine at UC San Diego School of Medicine and an infectious disease specialist at UC San Diego Health.

“With this type of adaptive study design, if remdesivir proves to be safe and active, the clinical trial may be rapidly adapted to remove the requirement for a placebo arm and add a treatment arm that includes other promising antiviral or other investigational drug to compare with the activity of remdesivir.”

Dan Sweeney, MD, associate clinical professor in the Division of Pulmonary, Critical Care and Sleep Medicine at UC San Diego School of Medicine, is co-principal investigator of UC San Diego-based trial.

The trial is projected to run to April 1, 2023 and will ultimately involve an estimated total of 440 participants. It is sponsored by the National Institute of Allergy and Infectious Disease.

  1. I have simplex 1 and on 400mg twice a day accilover tablets for 20yrs I think I’ve just had covid19 .. sore throat loss of taste smell . Lungs felt weird like I inhaled fine dust…. stomach ache . Head aches . And generally felt like crap what struck me an hour after my morning dose of accilover I felt a lot better! . Now 10 days of sore throat. Its getting better got taste and smell back feeling well . Q have I had covid19…………

  2. I am a 67 year old female who has used acyclovir for many years to fight fever blisters. People who experience fever blisters know the signs of the tingling in theeir lips that bring on the blisters and signals that a breakout is starting.. I was ill the end of January with a bronchial pneiumonia which was treated with antiobiotic and oral steroids. After a week I began to feel better but chest never loosened up so I wnt back to doctor. I received an inhaler and another round of oral steriouds. I have had many lung infecttions over the years, but this one was vastly different in onset and the way it behaved.

    As a consequence of being sick, my body reacts to that by a fever blister breakout. I keep acyclovir on hand and Zovorax so that I can treat the breakout quickly. The recommended time for treatment is 7 to 10 days,. I wound up taking the acyclovir for almost four weeks. I have never had a breakout last so long. I suspect I may have had COVID19 but only an antibody test would confirm that. I wondered if the acyclovir had an affect to help kill any other virus I might have had. I decided to explore the drugs being considered for use against this virus. My experienced has been that when I have an infection or other virus I usuall have a fever blister breakout either during or a few days after the illness is over. You may contact me for further inquiries.

  3. I had taken valcyclovir 1000mg for about 4 years to keep herpes in one eye from reappearing. My retina, without it, would have continued to scar. A change if diet really helped. I was able to discontinue daily use. Now I take it only during an outbreak. I think I only get sick about once every 2 to 3 years. Seems I have an outbreak during stress and prior to a bug setting in. This medication seems to work on other viruses.

  4. The year 2023 does not seem to impose the sense of urgency which this pandemic demands. It would seem that the estimates of death tolls this disease could inflict demand triple shift 24 hour 7 day a week crews at University and pharmaceutical company research labs to determine and or develop the drugs necessary to defeat the corona virus. This concern about “2023” as too lax could seem harsh, however, the global state of emergency continues to expand
    daily and that fact alone should be enough to encourage an extraordinarily exceptional effort. The corona virus treatment and vacine already exists waiting to be discovered.

  5. Kaiser Permanente’s generics are like placebos.
    Hope President Xi gets the disease his sick gov created.

  6. The day of the Super bowl, I developed a painful t’as on my left upper arm. Went to doctor the next day and was diagnosed with shingles and put on acyclovir. The following Thursday I developed a mild sore throat and aches that resolved over about 3 days. My wife then developed chills, aches and H/A that Sunday followed by fever of 101 and more. Fever lasted a week. She developed terrible cough lasting a good 2 weeks. She described as coughing a lung out. Interesting to me that I was taking the Acyclovir in that time frame. I am in the medical profession so am in constant contact with I’ll patients.

  7. I have been taken Valtrex for years. I truly believe this drug has kept me from getting sick from all types of viruses going around annually. There are times were I stop taken the Valtrex because I get tired of taking the pills. Recently, I started feeling run down, woke in the middle of the night with the worst sore throat I have ever experienced. I gargled with hydrogen peroxide, took 2 Valtrex plus my minocycline pill started feeling better mid-afternoon the next day. I have continued taking my Valtrex (take normally to prevent Shingles Outbreak) and minocycline (acne for face) ever since. I truly believe the Valtrex helps so many different types of viruses plus the minocycline is a plus. I truly believe this antiviral drug will save or help many people with COVID-19 symptoms or illness.

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