Evaluation of Prognostic Modification in COVID-19 Patients in Early Intervention Treatment

Coronavirus disease (COVID-19) is caused by SARS-COV2 and represents the causative agent of a
potential fatal disease generating a global public health problem. Person-to-person
transmission of COVID-19 infection led to the isolation of patients who subsequently received
a variety of treatments. Ivermectin treatment for safety is approved for human use by the FDA
in parasitic and skin infections. Studies report the therapeutic safety of Ivermectin in
humans with COVID-19, describing a 6.1-fold decrease in lethality compared to patients who
did not use Ivermectin (1.4 vs. 8.5%, p <0.0001). In this sense, the WHO and PAHO encourage
the use of unproven therapies in the context of a randomized clinical trial (RCT).
Anticoagulants have reported up to 20% in the reduction of mortality (heparin), Ribaroxaban
is effective with the inhibition of PAR1 / PAR2 / PAR4 receptors through the blocking of
Factor Xa and the formation of thrombin, having anti-inflammatory effects, decreasing
arteriosclerosis and platelet aggregation. There is a Telemedicine working method implemented
by the OOAD of the North Federal District, which detects early signs and symptoms of possible
complications and offers an early intervention treatment policy for first-level care
beneficiaries. Under this method, a quasi-experimental study showed that there is a
modification in the frequency of recovered patients of 80-90% in patients diagnosed with
COVID-19 after an early intervention treatment with paracetamol, Ivermectin, Azithromycin,
Ribaroxaban in patients with COVID -19 from UMF 13 during the period of July-August 2020.
Therefore, it is necessary to carry out a randomized clinical trial to confirm this
assertion.

Objective: To evaluate the percentage of patients with a diagnosis of COVID-19 who modify
their clinical evolution under a comparative treatment of early intervention in beneficiaries
of the U.M.F 13 and U.M.F 20 of the I.M.S.S., during the period of December 2020-January
2021.

Material and Methods: A randomized, single-blind, prospective, longitudinal and open
experimental study in 62 patients with COVID-19 from UMF No. 13 and No. 20 from November to
December 2020. Including 31 patients in group A (Azithromycin / Ivermectin / Ribaroxaban /
Paracetamol) and 31 patients in group B (Azithromycin / Ribaroxaban / Paracetamol). With
inclusion criteria over 18 years of age, have type 2 diabetes mellitus, Systemic Arterial
Hypertension, Obesity or overweight, PCR confirmation of COVID-19. For the video call, the
Family Medicine Units have Electronic Equipment Installation for Internet use. Exclusion
criteria are patients with severe COVID-19 (they deserve immediate referral to second level
of care, hospital). Elimination criteria are Prior informed consent, medication is given
randomly to a COVID-19 patient, a follow-up video call will be made at home for 14 days,
recording sex, age, education, date of disease onset, taking laboratories (hematic biometry,
C-reactive protein, D-dimer, Ferritin, prothrombin time, thromboplastin time, lactic
dehydrogenase) taken at the onset of the disease, taking as an outcome variable the
modification of the clinical course (clinical symptoms such as headache, cough, fever,
conjunctivitis , myalgias, arthralgias, rhinorrhea, odynophagia, anosmia, chest pain,
dyspnea) when granting treatment in groups A and B.. Statistical differences will be
evaluated using the Mann-Whitney U test with a power of 90% and a type I error rate of 1% for
the variable of modification of the clinical course in treatment groups A and B. analysis
will be performed in SPSS version 21.