Trump’s ‘shotgun therapy’ for COVID-19 – Well being and Life-style
By Rafael Castillo MD
We are so relieved that US President Donald Trump has been declared well recovered from COVID-19. In fact, he is considered fit and not infectious enough to go back to the campaign in a few days.
When the life of the most powerful person in the world is thrown out of whack due to a potentially fatal disease, the whole world is in a floating animation. The tension is now over and we return to regular programming.
Some texted me to ask if Trump’s medical team pressed the panic button and given him shotgun treatment, including experimental ones. We are not really in a position to assess the reasons for his treatment regimen, but the bottom line is that he did not have any serious side effects and appears to have recovered well.
Based on his official medical bulletins, he was given a monoclonal antibody cocktail (MAC), steroids, remdesivir, melatonin, famotidine, zinc and vitamin D.
I just want to discuss the three treatments that are now in clinical trials, and therefore considered experimental – MAC, melatonin, and famotidine.
The MAC is a combination of two antibodies, one from a person who has recovered from COVID-19 and the other from a mouse, using a genetically engineered immune system to simulate that of humans. The antibody cocktail targets the virus’ spike protein to inactivate it and prevent it from replicating exponentially within cells. Experimental studies in animals – hamsters and monkeys – have shown that this can potentially reduce virus levels and the severity of the disease.
Just two weeks ago, the manufacturer of the cocktail presented preliminary data from its ongoing clinical study on COVID-19 patients with asymptomatic or at most moderately severe disease. The results of the preliminary data suggested that those who were given them needed fewer visits to the doctor, but there was no clear evidence that they could prevent any more severe disease from getting worse. Trump, who was diagnosed with mild COVID-19, would have fit into the entry criteria for the clinical trial.
However, giving him this experimental treatment, the immediate and long-term side effects of which are not yet known, was a medical gamble for a person whose health outcome would have affected the whole world. For me, the risk-benefit ratio was more risky.
Famotidine is a common remedy for high blood pressure or heartburn. A clinical study testing the drug on COVID-19 patients in the New York hospital found that it may be helpful. However, since they were unable to recruit the required number of patients, their results were not statistically significant. The Feinstein Institute for Medical Research, which initiated the study, is starting another study on milder cases of COVID-19.
This drug has been around for decades and has been shown to be safe. So I wouldn’t mind giving Trump this drug either. After all, he also had steroids that can make an upset stomach so famotidine can help prevent this as well.
He was also given melatonin, a commonly available sleeping pill, but the dose wasn’t specified. It is believed to be higher than the usual recommended dose for improving sleep. Two U.S. based colleagues told me that the medical team may have referred to our published preliminary report on high dose melatonin (hdM) use in hospitalized COVID-19 patients. High-dose melatonin
The report “Melatonin as Adjuvant Treatment for Pneumonia Patients With Coronavirus Disease 2019 Who Needs Hospitalization (MAC-19 PRO): A Case Series” reported on 10 patients with moderate to severe COVID-19 who were admitted to Manila Doctors Hospital in the first month became the pandemic here that we have given hdM.
We published our preliminary experience in a U.S. journal last June, and the editor recognized it in its editorial as the first published report on the use of high-dose melatonin in actual COVID-19 patients.
In the report, we found that patients who were given hdM – compared to patients who were not given hdM (not hdM) in the same study period from March 5 to April 4, 2020 – had advantages in terms of recovery and the Prevention of severe showed disease and possibly survival. Clinical stabilization and / or improvement was seen within four to five days in all 10 patients who were administered hdM.
All hdM patients survived, including three with moderate acute respiratory distress syndrome (ARDS), which is the leading cause of death in COVID-19, and one with mild ARDS. None requires intubation and mechanical ventilation (MV) or connection to a ventilator or breathing apparatus. The patients who were administered hdM were discharged an average of about eight days after the onset of hdM, compared to the mean hospital stay of 13 days for those who were not administered hdM.
Although the groups were not comparable, 12 of the 34 (35.3 percent) COVID-19 (positive) died from swab test non-HDM patients admitted during the same period and seven (20.6 percent) required MV, while six of 15 (40 percent) non-hdM (negative) by swab test, but highly likely COVID-19 pneumonia patients also died, and four (26.7 percent) required MV. No significant side effects were noted with hdM, with the exception of drowsiness, which was considered beneficial by all patients, most of whom had previously had anxiety and symptom-related sleep problems. We concluded in the report that “hdM can play a beneficial role in patients being treated for COVID-19 pneumonia, resulting in shorter time to clinical improvement, lower need for MV, shorter hospital stay and possibly the lower risk of death. HdM was well tolerated. This is the first report to describe the benefits of hdM in patients being treated for COVID-19 pneumonia. Melatonin is an inexpensive sleep aid widely used around the world and could play a role as an adjuvant therapy in the global war on COVID-19. “
Clinical study is ongoing
A well-designed nationwide clinical trial of hdM in COVID-19 is currently underway by well-known lung specialist Dr. Camilo Roa Jr. is headed. It is funded by the Philippine Health Research and Development Council of the Department of Science and Technology and with this study we hope to confirm what was observed in the preliminary report. Everything is prepared for the process; The study group is just waiting for final approval from our Food and Drug Administration.
Last month, a group of domestic and foreign experts, including four former health ministry secretaries (Doctors Enrique Ona, Jimmy Galvez-Tan, Manuel Dayrit, and Paulyn Ubial), issued a consensus recommendation on the use of hdM in COVID. 19, from the confirmed but asymptomatic cases to the critically ill cases. This has been circularized here and in the United States. Our US colleagues say Trump’s medical team may have received this report as well.
Of the three experimental treatments Trump received, giving melatonin and famotidine had high benefit (especially melatonin) and low risk results in my opinion. But I would have thought twice before giving the monoclonal antibody cocktail. But who cares? He’s back in the dishes, and we should expect to hear more of his colorful remarks (Trumpisms), but hopefully less of his unconcerned concern about COVID-19.