Published on Mar 04, 2023
Hydroxychloroquine Covid 19 Study Results : Hydroxychloroquine and chloroquine are oral prescription drugs that have been used for treatment of malaria and certain inflammatory conditions. HCQ is likely to attenuate the severe progression of COVID-19, inhibiting the cytokine storm by suppressing T cell activation. It has a safer clinical profile and is suitable for those who are pregnant. It is cheaper and more readily available in China. We herein strongly urge that clinical trials are performed to assess the preventive effects of HCQ in both disease infection and progression.
Hydroxychloroquine and chloroquine are under investigation in clinical trials for pre-exposure or post-exposure prophylaxis of SARS-CoV-2 infection, and treatment of patients with mild, moderate, and severe COVID-19. More information on clinical trials can be found at ClinicalTrials.govexternal icon. FDA issued an Emergency Use Authorization (EUA) to authorize use of chloroquine and hydroxychloroquineexternal icon from the Strategic National Stockpile for treatment of hospitalized adults and adolescents (weight ≥50 kg) with COVID-19 for whom a clinical trial is not available or participation is not feasible.
Chloroquine phosphate and hydroxychloroquine sulfate are not FDA-approved for treatment of COVID-19. Some versions of chloroquine phosphate are approved by FDA for other indications—for prophylaxis and acute attacks of certain strains of malaria and for the treatment of extraintestinal amebiasis, but the chloroquine phosphate drug product covered by this letter has not been approved. Several versions of hydroxychloroquine sulfate are approved by FDA for prophylaxis of and treatment of malaria, treatment of lupus erythematosus, and treatment of rheumatoid arthritis. The safety profile of these drugs has only been studied for FDA approved indications, not COVID-19.
A clinical trial has begun to evaluate whether the malaria drug hydroxychloroquine, given together with the antibiotic azithromycin, can prevent hospitalization and death from coronavirus disease 2019 (COVID-19). The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring the trial, which is being conducted by the NIAID-funded AIDS Clinical Trials Group (ACTG). Teva Pharmaceuticals is donating medications for the study.
The Phase 2b trial will enroll approximately 2,000 adults at participating ACTG sites(link is external) across the United States. Study participants must have confirmed infection with SARS-CoV-2, the virus that causes COVID-19, and be experiencing fever, cough and/or shortness of breath. The investigators anticipate that many of those enrolled will be 60 years of age or older or have a comorbidity associated with developing serious complications from COVID-19, such as cardiovascular disease or diabetes. Participants will be randomly assigned to receive short-term treatment with either hydroxychloroquine and azithromycin or matching placebos. People living with HIV and pregnant and breastfeeding women also are eligible to participate in the study. The first participant enrolled today in San Diego, California.
As of May 13, the World Health Organization (WHO)(link is external) has reported 4.17 million cases of and 287,399 deaths from COVID-19 worldwide. In the United States, 1.36 million confirmed COVID-19 cases and 82,246 deaths have been reported as of May 13, according to the Centers for Disease Control and Prevention (CDC)(link is external).
Currently, there are no specific therapeutics approved by the U.S. Food and Drug Administration to treat people with COVID-19. Hydroxychloroquine is FDA-approved to prevent and treat malaria, as well as to treat the autoimmune diseases rheumatoid arthritis and lupus. Some preliminary reports have suggested that hydroxychloroquine, alone or in combination with the FDA-approved antibiotic azithromycin, may benefit people with COVID-19. Numerous clinical trials are planned or underway, including a recently launched study supported by NIH’s National Heart, Lung and Blood Institute evaluating the safety and effectiveness of hydroxychloroquine for treatment of adults hospitalized with COVID-19. On March 28, FDA issued an Emergency Use Authorization(link is external) (EUA) to allow hydroxychloroquine and medical-grade chloroquine to be distributed from the Strategic National Stockpile and prescribed by doctors to hospitalized adolescents and adults with COVID-19, as appropriate, when a clinical trial is not available or feasible.
The main objective of the study is to determine whether hydroxychloroquine and azithromycin can prevent hospitalization and death due to COVID-19. Additionally, investigators will evaluate the safety and tolerability of the experimental treatment for people with SARS-CoV-2 infection. While hydroxychloroquine and azithromycin are both considered safe in most people, they can cause side effects ranging from headache and nausea to, rarely, heart rhythm problems that can be life-threatening. Because of the risk of heart problems when hydroxychloroquine is used alone or combined with azithromycin, FDA cautions that use of hydroxychloroquine for COVID-19 should be limited to clinical trials or for treating certain hospitalized patients under EUA(link is external) so clinicians can monitor patients for adverse effects.
The lungs are the organs most affected by COVID-19 because the virus accesses host cells via the enzyme ACE2, which is most abundant in the type II alveolar cells of the lungs. The virus uses a special surface glycoprotein, called "spike", to connect to ACE2 and enter the host cell. The density of ACE2 in each tissue correlates with the severity of the disease in that tissue and some have suggested that decreasing ACE2 activity might be protective, though another view is that increasing ACE2 using Angiotensin II receptor blocker medications could be protective and that these hypotheses need to be tested. As the alveolar disease progresses, respiratory failure might develop and death may follow.
The virus is thought to be natural and have an animal origin, through spillover infection. It was first transmitted to humans in Wuhan, China, in November or December 2019, and the primary source of infection became human-to-human transmission by early January 2020. The earliest known infection occurred on 17 November 2019
According to the WHO, the use of masks is only recommended if a person is coughing or sneezing or when one is taking care of someone with a suspected infection.
To prevent transmission of the virus, the CDC recommends that infected individuals stay home except to get medical care, call ahead before visiting a healthcare provider, wear a face mask when exposed to an individual or location of a suspected infection, cover coughs and sneezes with a tissue, regularly wash hands with soap and water and avoid sharing personal household items. The CDC also recommends that individuals wash hands often with soap and water for at least 20 seconds, especially after going to the toilet or when hands are visibly dirty, before eating and after blowing one's nose, coughing, or sneezing. It further recommended using an alcohol-based hand sanitizer with at least 60% alcohol, but only when soap and water are not readily available. For remote areas where commercial hand sanitizers are not readily available, WHO suggested two formulations for the local production. In both of these formulations the antimicrobial activity of ethanol or isopropanol is enhanced by low concentration of hydrogen peroxide while glycerol acts as a humectant. The WHO advises individuals to avoid touching the eyes, nose, or mouth with unwashed hands. Spitting in public places also should be avoided
Social Distancing is a non-pharmaceutical infection prevention and control intervention implemented to avoid/decrease contact between those who are infected with a disease causing pathogen and those who are not, so as to stop or slow down the rate and extent of disease transmission in a community. This eventually leads to decrease in spread, morbidity and mortality due to the disease. In addition to the proposed interventions, the State Governments may prescribe such other measures as they consider necessary.
