Abstract
Background. There is an emergency need for early ambulatory treatment of
COVID-19 in acutely ill patients in an attempt to reduce disease
progression and the risks of hospitalization and death.
Methods and Results. We recently reported results on 320 high-risk (age
> 50 with ≥ 1 comorbidity) COVID-19 cases and have updated
our results with 549 additional cases in period ending December 16,
2020. Our protocol utilizes at least two agents with antiviral activity
against SARS-CoV-2 (zinc, hydroxychloroquine, ivermectin) and one
antibiotic (azithromycin, doxycycline, ceftriaxone) along with inhaled
budesonide and/or intramuscular dexamethasone. Albuterol nebulizer,
inhaled budesonide, intravenous volume expansion with supplemental
parenteral thiamine 500 mg, magnesium sulfate 4 grams, folic acid 1
gram, vitamin B12 1 mg, are administered for severely ill patients who
either present or return to the clinic with severe symptoms. In period 1
(April-September, 2020) 6/320 (1.9%) and 1/320 (0.3%) patients that
were hospitalized and died, respectively. In period 2,
(September-December, 2020) 14/549 (2.6%) and 1/549 (0.18%) were
hospitalized and died, respectively. For comparison, we used the
Cleveland Clinic COVID-19 hospitalization calculator and based on
average age and comorbidities the expected rate of hospitalization for
both periods was 18.5%. The cumulative mortality among confirmed and
suspected COVID-19 in Collin, Dallas, Denton, and Tarrant counties was
0.76, 1.04, 0.90, and 0.97. As a result, our early ambulatory treatment
regimen was associated with estimated 87.6% and 74.9% reductions in
hospitalization and death respectively, p<0.0001.
Conclusions. We conclude that early ambulatory, multidrug therapy is
associated with substantial reductions in hospitalization and death
compared to available rates in the community. Prompt ambulatory
treatment should be offered to high-risk patients with COVID-19 instead
of watchful watching and late-stage hospitalization for salvage
therapies.
Key words: SARS-CoV-2; COVID-19; multidrug; hospitalization; mortality;
ambulatory; antiviral; zinc; hydroxychloroquine; ivermectin;
doxycycline; azithromycin; vitamin; corticosteroid
The epidemic viral outbreak of SARS-CoV-2 infection (COVID-19) is
advancing across the United States unabated as mass vaccination is
attempted too late in the pandemic.11McCullough PA, Eidt J,
Rangaswami J, Lerma E, Tumlin J, Wheelan K, Katz N, Lepor NE, Vijay K,
Soman S, Singh B, McCullough SP, McCullough HB, Palazzuoli A, Ruocco
GM, Ronco C. Urgent need for individual mobile phone and institutional
reporting of at home, hospitalized, and intensive care unit cases of
SARS-CoV-2 (COVID-19) infection. Rev Cardiovasc Med. 2020 Mar
30;21(1):1-7. doi: 10.31083/j.rcm.2020.01.42. PMID: 32259899. There
are currently no approved drugs or drug combinations in the U.S.
indicated for the ambulatory treatment of COVID-19 or its complications.
Unfortunately, there are no potentially conclusive randomized trials of
multidrug therapy underway at this time. As with all serious medical
conditions, there is a role for empiric treatment in an attempt to
reduce fatalities.22McCullough PA, Oskoui R. Early multidrug
regimens in new potentially fatal medical problems[J]. Reviews in
Cardiovascular Medicine, 2020. 21(4): 507-508 This brief report gives
an update on real world data and the clinical outcomes associated with
an empiric multidrug regimen for confirmed COVID-19 patients who present
to a single ambulatory clinic in McKinney, which is located in Colin
County, Texas, U.S.
We have previously reported on
the methods undertaken by primary care providers consisting of a lead
physician (BCP) and four advanced practice practitioners (CR, VP, ES,
CH) in their care of acutely ill patients with suspected SARS-CoV-2
infection.33Procter BC, Ross C, Pickard V, Smith E, Hanson C,
McCullough PA. Clinical outcomes after early ambulatory multidrug
therapy for high-risk SARS-CoV-2 (COVID-19) infection. Reviews in
Cardiovascular Medicine, 2020, 21(4): 611-614. In brief, all patients
underwent contemporary real-time polymerase chain reaction (PCR) assay
tests from anterior nasal swab samples. Risk stratification and advised
nutraceuticals were in line with previously published guidance as shown
in Figure 1.44McCullough,
P. (2020). Innovative Early Sequenced Multidrug Therapy for Sars-Cov-2
(Covid-19) Infection to Reduce Hospitalization and Death.
International Journal of Medical Science and Clinical Invention,
7(12), 5139-5150. https://doi.org/10.18535/ijmsci/v7i12.02 All
patients received empiric treatment on the first day of presentation in
most cases before COVID-19 test results and treatment was continued for
those with confirmed COVID-19. Our protocol utilized at least two agents
with antiviral activity against SARS-CoV-2 (zinc, hydroxychloroquine,
ivermectin) and one antibiotic (azithromycin, doxycycline, ceftriaxone)
along with inhaled budesonide and/or intramuscular dexamethasone.
Albuterol nebulizer, inhaled budesonide, intravenous volume expansion
with supplemental parenteral thiamine 500 mg, magnesium sulfate 4 grams,
folic acid 1 gram, vitamin B12 1 mg, were administered for severely ill
patients who either present or return to the clinic with severe
symptoms.55Flannery AH, Adkins DA, Cook AM. Unpeeling the
Evidence for the Banana Bag: Evidence-Based Recommendations for the
Management of Alcohol-Associated Vitamin and Electrolyte Deficiencies
in the ICU. Crit Care Med. 2016 Aug;44(8):1545-52. doi:
10.1097/CCM.0000000000001659. PMID: 27002274. Additionally, for the
severely ill population dexamethasone 8 mg and ceftriaxone 1 gram was
administered intramuscularly. All patients had in-person or telemedicine
followup at 48 hours and as need depending on the duration and intensity
of symptoms.66Colbert GB, Venegas-Vera AV, Lerma EV. Utility of
telemedicine in the COVID-19 era. Reviews in Cardiovascular Medicine,
2020, 21(4): 583-587. Hospitalization and death data were collected
on followup telemedicine visits or calls to family members.
In period 1 (April-September, 2020) 6/320 (1.9%) and 1/320 (0.3%)
patients were hospitalized and died, respectively. In period 2,
(September-December, 2020) 14/549 (2.6%) and 1/549 (0.18%) were
hospitalized and died, respectively. For comparison, we used the
Cleveland Clinic COVID-19 hospitalization calculator and based on
average age and comorbidities the expected rate of hospitalization for
both periods was 18.5%.77Jehi,
L., Ji, X., Milinovich, A., Erzurum, S., Merlino, A., Gordon, S.,
Young, J. B., & Kattan, M. W. (2020). Development and validation of a
model for individualized prediction of hospitalization risk in 4,536
patients with COVID-19. PloS one, 15(8), e0237419.
88https://riskcalc.org/COVID19Hospitalization/
(accessed January 2, 2021) The cumulative mortality among confirmed
and suspected COVID-19 in Collin, Dallas, Denton, and Tarrant counties
was 0.76, 1.04, 0.90, and
0.97.99https://txdshs.maps.arcgis.com/
(data cutoff December 16, 2020) As a result, our early ambulatory
treatment regimen was associated with estimated 87.6% and 74.9%
reductions in hospitalization and death respectively,
p<0.0001.
Our results are consent with those of Zelenko and colleagues who
demonstrated that early treatment of COVID-19 in the surge of acute
cases in New York City was associated with 84% and 80% reductions in
hospitalizations and death respectively.1010Derwand R, Scholz M,
Zelenko V. COVID-19 outpatients: early risk-stratified treatment with
zinc plus low-dose hydroxychloroquine and azithromycin: a
retrospective case series study. Int J Antimicrob Agents. 2020
Dec;56(6):106214. doi: 10.1016/j.ijantimicag.2020.106214. Epub 2020
Oct 26. PMID: 33122096; PMCID: PMC7587171. We anticipate that the
widespread use of therapeutic antibodies directed against the spike
protein of SARS-CoV-2 administered at the site of diagnosis (emergency
room, urgent care clinic, nursing home) in addition to the use of
anticoagulants in high risk patients will greatly bolster the ambulatory
treatment of COVID-19 and have a substantial impact on the rate of
hospitalization.4 Given the novelty of early
ambulatory treatment and the lack of guidelines for outpatient treatment
of COVID-19, we infer the majority of current hospitalizations and
deaths in our region and likely the entire country receive no treatment
before hospitalization where salvage treatments are
undertaken.1111Hayek SS, Brenner SK, Azam TU, Shadid HR, Anderson
E, Berlin H, Pan M, Meloche C, Feroz R, O’Hayer P, Kaakati R, Bitar A,
Padalia K, Perry D, Blakely P, Gupta S, Shaefi S, Srivastava A,
Charytan DM, Bansal A, Mallappallil M, Melamed ML, Shehata AM,
Sunderram J, Mathews KS, Sutherland AK, Nallamothu BK, Leaf DE;
STOP-COVID Investigators. In-hospital cardiac arrest in critically ill
patients with covid-19: multicenter cohort study. BMJ. 2020 Sep
30;371:m3513. doi: 10.1136/bmj.m3513. PMID: 32998872; PMCID:
PMC7525342. Thus, it is important for media and public health
messaging to feature early ambulatory treatment as an option for those
acutely ill with COVID-19.1212Venegas-Vera AV, Colbert GB, Lerma
EV. Positive and negative impact of social media in the COVID-19 era.
Reviews in Cardiovascular Medicine, 2020. 21(4): 561-564
In conclusion, our data suggest more than three quarters of
hospitalizations and death are avoidable with early ambulatory treatment
by primary care teams. Supported by our durable results, we believe
early multidrug, ambulatory treatment should be offered as an emergency
measure in acutely ill, high-risk COVID-19 as a strategy to reduce
hospitalization and death. In our opinion, ambulatory treatment is
preferable to hospitalization for salvage therapies that are applied too
late and associated with complications and in-hospital death.
Figure 1. Early sequential multidrug therapy utilizing risk
stratification and available nutraceuticals, appropriately prescribed
approved drugs, and U.S. Food and Drug Administration Emergency Use
Authorization agents (reproduced with permission from
reference)4
Figure 2. Comparative results for COVID-19 hospitalizations and death
from for early ambulatory treatment of COVID-19 compared with estimated
risk of hospitalization and death from the Cleveland Clinic COVID-19
Hospitalization Risk Calculator and from the average case fatality rate
in the four county surrounding region of the clinic.78 9