6. What Are the Treatments for COVID-19?
a. What are the Potential Vaccines?
Technically, the question What are the Treatments for COVID-19 does not apply to vaccines. The patients are not given a vaccine if they already have COVID-19. But, they are discussed here because a vaccine is a means for preventing a person from getting COVID-19. The following are a few of the potential vaccines. There are many candidates being proposed, both in this Country and elsewhere.
1. Pfizer and BioNTech have completed their Phase III trails. They had 43,000 participants in the trial. There were 162 confirmed cases in the control and 8 in the vaccine group. This represents a 94.3 percent success rate. There were no serious side effects noted.
2. Johnson & Johnson has commenced Phase III single dose vaccine studies. This will include enrolling 60,000 vaccine candidates.
3. AstraZeneca has reported 95% efficiency in the over 65 group.
4. Moderna MRNA-1273 enrolled 30,000 people in their phase II trials and 25,654 had received their second dose. This vaccine is not made from a weaken Coronavirus.
b. What are the Treatment Drugs?
Information on treatment drugs is changing rapidly as new studies are being published. The following is provides as a partial list.
1. Convalescent Plasma Therapy.
Convalescent plasma therapy has been around since the 1880. It was used successfully to treat diphtheria, scarlet fever, Spanish Flu, hemorrhagic fever, chickenpox, and a large number of others. The SARI virus illness showed a 75% reduction in mortality compared to a placebo or no therapy. This is discussed in a scientific study in the Italian National Blood Centre.
The Mayo Clinic rates the risks of Convalescent plasma as low.
In June 2020 the New England Journal of Medicine reported a randomized clinical study that showed an improvement of 10% (134 verses 121 for standard of care) in a 5-day treatment group and an improvement of 4% (126 versus 121) in a 10-day treatment group. [https://www.gilead.com]
In April 2020 the National Institute of Health reported in a randomized clinical study of 1063 patients that Remdesivir reduced the hospitalization time from 15 days to 11 days or a 31% improvement and the mortality reduction from 11.6% to 8%. That is an improvement of 31%.
The European Medicine Agency for the European Union recommended the use of Remdesivir in the treatment of COVID19.
A study by WHO Solidarity Consortium on October 15, 2020 concluded that Remdesivir did not have any effect on the death rates from COVID19. This was a study of some 11,000+ randomized participants.
The FDA approved the use of Remdesivir for the treatment of Covid19 on October 22, 2020. This appears to be a rebuke of the WHO study that came out one week earlier.
3. Hydroxychloroquine and Chloroquine
In June 2020 a French study was concluded from a small non-randomized study. It measured the amount of viral shedding of SARS-CoV-2 virus after treatments with hydroxychloroquine alone (a common malaria drug) and in combination with azithromycin (Z-pack-a common antibiotic). The results showed that after 6 days there was a lower amount of shedding. This indicates that the drug was effective in reducing the COVID19 infection. [Gautret P, et.al. (2020) Clinical and
microbiological effect of a combination of hydroxychloroquine and azithromycin
in 80 COVID-19 patients with at least a six-day follow up: a pilot
observational study. Travel Med Infect Dis 2020b;34:101663]
This sent shock waves through the media as a potential treatment to COVID-19. President Donald Trump, touted the benefits on national television. The drugs were both proven safe over the last 40 years, neither drug was protected by patents, and the drugs were available and cheap to manufacture. When President Trump touted this product the main stream media began condemning its use. A race began to determine if hydroxychloroquine was effective in treating COVID-19.
- A small non randomized trial was held in the Veterans Hospital system and did not show an effect on seriously ill or near death patients. [Magagnoli J, Narendran S, Pereira F, Cummings T, Hardin JW, Sutton SS, et al.
Outcomes of hydroxychloroquine usage in United States veterans hospitalized
with Covid-19. MedRxiv. 2020 preprint] 2020] This study was funded by many large pharmaceutical companies.
- A search of registry data of some 96,000 patient medical records of COVID19 hospitalizations was done. It concluded that there was no significant evidence that hydroxychloroquine or chloroquine had any affect on the outcome of COVID19 patients. This study was funded by many large pharmaceutical companies. The study was published on May 22, 2020. A review showed significant inconsistencies in the data and the principle authors refused to vouch for its authenticity. The publication was retracted.
- A study was done to determine if Hydroxychloroquine had prophylaxis effect with occupational or household exposure was done. The participants were solicited via social media by volunteering and the study participants were self reporting. The study reported no prophylaxis affect. [Boulware DR, et al. A randomized trial of hydroxychloroquine as postexposure prophylaxis for Covid-19. N Engl J Med. 2020 Jun 3 ] This kind of study is considered anecdotal and lacked scientific rigor.
- Recently a randomized clinical study of 2000+ patients was accepted for publication on June 29, 2020. It showed that the the use of hydroxycholoroquine improved the survivability from 75% using standard treament to 85%. [Arshad S et. al (2020) Treatment with Hydroxychloroquine, azithromycin and combination in patients hospitalzied with COVID19, International Journal of Infectious Diseases Vol 97]
- The biochemical mechanism for reducing the virus replication is believed to be that the hydroxychloroquine reduces the acidity within the host cell from a pH of 4 to 6 thereby entombing the viral particles.
- An Italian study reported some benefits from hydroxychloroquine. [Monforte et al (7-29-2020) Effectiveness of hydroxychloroquine in COVid-19 Disease, International Journal of Infectious Diseases (doi.org/10.1016/j.ijid.2020.07.0560)]
- A Korean study showed some positive effects from Hydroxychloroquine in both in-vitro and in-vivo clinical studies. [Zou et al. (accepted 26 July 2020) Hydroxychloroquine and chloroquine: A potential and Controversaial treatment for COVID-19, Arch. Pharm. Res.]
- An Italian Observational Study of 33 hospitals and 3451 patients showed a benefit from Hydroxychloroquine using a 200 mg dose rate. [ , August 25, 2020]
- A combination of Hydroxychloroquine and Vitamin D appeared to have beneficial effects on Covid-19 mortality in a Spanish Study.
- A woman with Lupus had been taking hydroxychloroquine for 19 years and came down with COVID-19. She was hospitalized for 7 days and released. Lupus is a co-morbidity for serious complications in COVID-19.
- A study by WHO Solidarity Consortium on October 15, 2020 concluded that Hydroxychloroquine did not have any effect on the death rates from COVID19. This was a study of some 11,000+ randomized participants. A potential problem appears that in this study they gave their patients 2000 mg of hydroxychloroquine on the first day and 800 mg/day for 10 days thereafter. The FDA when it allowed Hydroxychloroquine for emergency treatment of COVD19 specified that maximum first day dosage should be no greater than 800 mg. and then no more than 400 mg thereafter. The Italian study of 3451 patients used 200 mg/day dosing rates and showed benefits. The WHO investigation may raise serious dosing issues.
The results showed that Dexamethasone had a dramatic reduction in deaths associated with the treatment of Covid-19. The link allows a download of the full report. The Mayo Clinic stated:
Studies have found that it reduces the risk for deaths by about 30% for people on ventilators and by about 20% for people who needed supplemental oxygen.
The FDA approved Dexamethaone for optical inserts on November 30, 2018. It has emergency use for treating COVID-19 patients.
5. REGEN-cov2 Antibody Cocktail
This is an experimental drug that is currently in phase 2 clinical trials. It has shown positive results in reducing the viral load in infected COVID-19 patients. The greatest treatment benefits were reported in non-hospitalized patients who had not started their own natural immune response. This means early treatment had the best results. Monoclonal antibodies have been used in cancer treatments with limited success.
President Trump took this drug and had an extremely fast recovery.
The FDA approved the emergency use of this drug to treat COVID-19 on November 21, 2020.
This is an anti-viral drug used in Japan to treat influenza. It has been approved in Russia, China and India to treat COVID19. There are several clinical studies ongoing to establish the effectiveness. Some non-randomized studies with small patient size has shown some effect on reducing viral shedding. A small study in China on 236 adults showed an improvement in recovery rates. A small non-randomized Russian study found favipiravir and hydroxychloroquine both had beneficial effects on COVID-19. [Ivashchenko et al (08-15-2020) Avifavir for Treament of Patients with Moderate COVID-19, manuscript submitted for publication.]
This is an anti-inflammatory drug. It has limited anecdotal and clinical data. In a small clinical trial, it showed a 10 day survival rate of 97% verses 83% from the control group. There is a phase 3 clinical trial ongoing.
8. Nitric Oxide
This is a vasodilator for those having severe pulmonary distress. There are 9 clinical studies ongoing.
This drug is being investigated for combating cytokine storm in severely ill patients. It showed a decrease of 25% of hospitalizations from the baseline to 7 days. One study showed no significant difference between Ruxolitinib and a placebo. There are numerous clinical studies ongoing including two phase 3 clinical trials.
This drug was developed for fighting cytokine release syndrome (CRS), aka cytokine storm, in COVID-19 patients with moderate to severe ARDS. A small randomized clinical trial in India showed that out of 30 patients who took the drug, none died and all recovered compared to 15% that died in the 20 patients in the control group. The product has been approved in India for emergency use in COVID-19 patients.
This is an FDA approved drug to kill head lice. It is well tolerated from a safety standpoint. In a small study of 16 patients with COVID19 that took Invermectin 100% were cured compared to the control group. In another study 173 hospitalized patients with COVID19 had a mortality of 15% compared to 25.2 percent in the control group. There are several clinical trials in progress. There was a phase III clinical trial done on 400 patients. The results showed 0 deaths applicable to Invermectin + Doxycycline and 3 deaths applicable to the placebo group. There were 2 complications with the Ivermectin group related to erosive esophagitis. Another study completed in October 2020 showed that morbidity was reduced from 25% in the control group to 15% in the Ivermectin group. A publication in Antiviral Research entitled “The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro” reported a 500 fold reduction in the virus after 48 hours. There are many clinical trials ongoing.
12. Vitamin D.
Vitamin D has not been approved by the FDA to treat COVID-19. On the other hand, it is available over-the-counter and is well tolerated. The Lancet reported in September 2020 that there is evidence that Vitamin D deficiency can be connected with COVID19 mortality.
That is, if the Vitamin D level is too low, it may aggravate the complications of COVID-19.
Dr. Simonson opined that Vitamin D treatment could reduce the onset of cytokine storm associated with COVID19.