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Despite the success of the COVID-19 vaccine and the use of non-pharmacological medical interventions, the global need for an effective SARS-CoV-2 treatment remains high. Currently, recombinant antibodies (dexamethasone, docerisumab, salilumab), monoclonal antibodies and antiviral drugs (remdesivir, molonopravir, nelmatrifir) are used to treat various degrees of COVID-19.

Ivermectin, used in the oral treatment of Govit-19, is an inexpensive, mild, and widely available antiseptic. Experimental studies demonstrated the inhibitory effect of ivermectin for sale on SARS-CoV-2.

In 2021, two randomized clinical trials conducted in Colombia 16 and Argentina 17 showed that ivermectin for sale did not significantly affect remission and hospitalization rates for patients with COVID-19.

Despite these effects, ivermectin for sale has been strongly recommended for the treatment of covid-19, but the World Health Organization (WHO) recommends that its use be limited to clinical trials. An ongoing randomized clinical trial is evaluating the effect of ivermectin for sale on acute immunization in patients at risk for COVID-19 infection in Malaysia.

Method

The clinical efficacy study of Ivermectin (I-Tech) Sarkar-19 was conducted from May 31 to October 25 in 20 general hospitals and in high-risk patients at a COVID-19 isolation facility in Malaysia. This is a blind randomized clinical trial. 2021. The study was approved by the National Council for Medical Research (NMRR-21-155-58433) and registered with ClinicalTrials.gov (NCT04920942). All participants gave written and informed consent.

Patients at risk of mild or moderate infection should be treated in a COVID-19 isolation center for at least 10 days or, if symptoms persist, immediate intervention if severe.

The study included patients who had undergone reverse transcription polymerase chain reaction (RT-PCR) testing or tested for COVID-19 antigen. This patient has at least one associated infection and a mild to moderate infection (COVID-19, Malaysia). Clinical severity 2 or 3 within 7 days of onset of symptoms; WHO medical success rate 2-4). Asymptomatic patients with a residual pulse oxygen (Spo2) less than 95% are excluded. Severe liver failure (alanine aminotransferase level 10 times higher than normal), serious medical or surgical trauma, viral infection, pregnancy or breastfeeding, favipiravir, ivermectin for sale or Jovit-19 (favivir, hydroxychlorovirin, 7). Compliance criteria are specified in (Appendix 1). Researchers collected ethnic information based on a Malaysian patient card or passport (for non-Malaysian nationals).

All patients with COVID-19 were treated according to the National Guidelines for the Management of Patients with COVID-19, which were developed by a group of local experts based on consensus, WHO recommendations and NIH guidelines. Peopleolder then 50 years of age are more at risk. Patients are stabilized according to clinical severity of disease onset and disease course: stage 1, asymptomatic. Stage 2, asymptomatic pneumonia. Stage 3 – signs of pneumonia without hypoxia; Stage 4, hypoxic and hypoxic pneumonia, is markedly altered by multi-organ infection. Stages 2 and 3 are classified as mild to moderate (WHO level 2-4) and stages 4 and 5 (WHO level 5-9) as severe. Standard care and monitoring of clinical outcomes in patients with mild or moderate symptoms.

Intervention and data collection

All information related to the study was recorded in CNS report format and included in the Research Electronic Data Capture (REDCAP) database. 22.23 Patients receiving oral buy ivermectin 1: 1 (0.4 mg / kg body weight daily for 5 days) will receive standard or standard therapy with group or group therapy. REDCap was randomized to a randomized trial that identified random interference with computer programs in all areas of the study. 2-6 is a random index of a random sequence of scenes.

Interruption

The buy ivermectin used in the study was obtained from Maxford Healthcare, a WHO-licensed pharmaceutical company that reported buy ivermectin production. Buy ivermectin was not known in Malaysia at the time of the study. Therefore, the product is of legal age and will be used in this clinical trial with the necessary approval from the National Medicines Authority.

The dose of buy ivermectin in each intervention group was approximately 6 mg or 12 mg or approximately 6 mg tablets (Dosage Table of the Study Protocol, Appendix 1). The first dose of buy ivermectin was randomized on the first day of admission and then 4 doses every 2-5 days. Patients may receive better absorption before or after taking the medicine. Administration, distribution and sex of ivermectin.

Point section

The first result is a subset of patients ready for malignant COPD, defined as the hypoxic zone, where Spo2 supports> 95% of adjuvant therapy (for COPD). Clinical risk factors are required. 19 Malaysia 4 or 5). Exceptions 5-9). Spo2 is measured with oximeter pulses according to clinical monitoring protocols.

The second epidemic is serious illness and the number of patients hospitalized for 28 days, the intensity of the air force, hospital care, and the length of hospital stay after admission. Entry. Negative and severe NES (SAE) were screened and version 5.0 according to standard entry criteria. All results were recorded at random to exit the study within 28 days of enrolment, regardless of what happened earlier.

Analysis group

Previously, a cohort was analysed for COVID-19 vaccine status, age, hospital status, duration of hospitalization, and overall morbidity.

The road

We pre-recorded patients ’clinical history, quality of behaviour, blood samples for routine blood testing, kidney and liver data, C-reactive protein levels, and radars. All study findings were reviewed in the database and reviewed by a safety monitoring committee.

Define the pattern

According to the latest local data, the chance of early surgery is 17.5% in the control group of patients at high risk for mild to moderate disease, with a 9% reduction in the difference between the intervention and control groups. Sample size means 5% speed and 80% performance for two-sided tests. Two group of 250 patients (total 500 people) were randomized to treatment.

Statistical analysis

Moderate care and safety screening should be followed for initial surgical therapy if patients in the intervention group receive at least one dose of ivermectin compared to all patients in the control group. The susceptibility of all affected patients in the intervention group who did not receive ivermectin (TAPO) was also examined.

Mixed ANOVA analysis was used to determine whether changes in laboratory studies were due to interactions between the study group (in patient units) and time point (in patient units), and were considered significant at P number <0.05.

For the first 150 and 300 patients, between July 13, 2021 and August 30, 2021, the agreed total critical levels were P <0.05, respectively, and were measured and placed within the O’Brien-Fleming cut-off threshold. … If efficacy data are P <0.003, treatment may be considered discontinued as soon as possible. Result: Data Protection Security Audit Problem: Submitted: Inquiry Recommendation or Procedure: First Closed: Unknown.

The result:

In 2021, from January 31st to January 9th, my visit is unlimited. About 500 patients. The last patient was released on October 25, 2021, followed by Mamapavan. Four patients were then excluded: state disorder. Follow-up: The patient is confirmed to have dengue. In the intervention group, 2 patients did not meet selection criteria because of symptoms and negative COVID-19 RT-PCR testing for more than 7 days, whereas 1 patient developed acute coronary syndrome before initiating ivermectin therapy. .. And then the middle. Changed therapeutic population for primary analysis 490 patients (98% reported), Jesus 241 intervention group 249 seats control group (image) standardized drug analysis or intervention 232 patients: (96.3%) Ivermectin: 5 doses.

Basic demographics and patient characteristics were controlled for between groups (Table 1). Mean (SD): 62.5 (8.7) per year, 267 women: (54.5%) location; 254 patients (51.8%) 2 complete doses of Covid-19: discontinued. The survey of major ethnic groups is well represented in the Malaysian census. Hypertension (369 [75.3%], diabetes (262 [53.5%)], dyslipidaemia (184 [37.6%]), and obesity (117 [23.9%]] were common.

The mean (SD) of symptomatic colonies at the time of admission was 5.1 (1.3). Most were cough (378 [77.1%), fever (237 [48.4%), and nasal congestion (149 [30.4%)], and baseline neutrophil-to-lymphocyte ratios and serum C-reactive protein levels were similar. All groups. None of the major drug compounds taken in either group were significant. Numerical values ​​such as sensitivity analysis, clinical problems and basic instruction

Key findings

There were 490 patients in 95 (19.4%) patients during the study period. Seriously: It doesn’t work. Of 241 patients, 52 (21.6%) received ivermectin and 43 (17.3%) of 249 received standard care (RR, 1.25; 95% CI, 0.87-1.80; P = 0.80). 25) (Table 2). Sensitivity analysis of treated populations

Secondary results

The survey predicted the outcome of the second largest control group. Yes, severity: not serious, start time: ivermectin and constraints 51). Comparison of the control group (RR, 0.41; 95% CI, 0.13-1.30; p = 17) with ivermectin group 4 patients (1.7%) with mechanical ventilation: neglected, flashy: care unit 6 patients. . . (2.5%) V. (3.2%) (RR, 0.78; 95% CI, 0.27-2.20; P = 0.79). The same 28-day-hospital mortality (3 [1.2%] versus 10 [4.0%]; RR, 0.31; 95% CI, 0.09-1.11; P = 0.11.9) was found in the ivermectin and control groups. After the admission period. Stay duration (median [SD], 7.7 [4.4] days, 7.3 [4.3] days, mean difference: 0.4; 95% CL, 00.4–1, 3; P). = 0.38).

The proportion of patients who reached the target 5 days after enrolment was similar in the 2 groups (RR, 0.97; 95% CI, 0.82–1.15; P = 0.72). Day 5 was similar in the presence of pneumonia or chest radiograph obstruction (RR, 1.03; 95% CI, 0.76 to 1.40; P = 0.92). References from blood test criteria are important: both are not visible. The complication of the disease, or rather, is notable for most life cycles: interneuronitis

Subgroup analysis

Complicated diseases: a subgroup analysis of Yucatan disease was identified (Table 3). The total number of patients who received the vaccine was 22 (17.7%) in the ivermectin group and 12 (9.2%) in the control group.

Contradictory facts

A total of 55 adverse events were diagnosed in 44 patients (9.0%) (Table 4). Of these, 33 belonged to the ivermectin group and diarrhea was the most common adverse reaction (14 [5.8%). There were 5 cases of SAE, 4 groups ivermectin (secondary hypovolemic shock, 2 myocardial infarctions, 1 severe anemia, and 1 severe diarrhea) and 1 severe exacerbation. Most of the Class 1 adverse events were resolved during the study.

Of the 13 deaths, acute Covit-19 was the immediate cause of pneumonia (9 deaths [69.2%). Four patients in the control group is no more now because of sepsis at the hospital. Ivermectin treatment does not cause death.

Tell me

Randomized clinical trials of ivermectin in adults with mild to moderate Govt-19 disease and other co-morbid conditions did not show evidence that ivermectin was effective in reducing the risk of serious disease.

Randomized clinical trials of ibolysin in Govit-19 patients and more than 400 patients focused on outpatient therapy. In contrast, higher ivermectin binding was observed when patients in our study were hospitalized. Also, well-defined criteria were used to confirm the progression of acute disease.

Prior to the trial, the COVID-19 mortality rate in Malaysia was about 1%, which was very low as the initial end point of our study. Even in the risk group, 13 people died (2.7%). In a recent meta-analysis of eight randomized clinical trials of ivermectin in the treatment of SARS-CoV-2 infections, 71 (3.8%) of 1848 patients died, which had an effect on drug survival.

The pharmacology of ivermectin in the treatment of Govit-19 is controversial. Ivermectin is highly resistant to SARS-CoV-2 in plasma concentration. Dosage duration 0.2 mg / kg Single dose 0.6 mg / kg / day 5 days 29-32 Positive results for Covid-19. Kroleviki et al. showed a concentration-based antiviral effect. Pharmacological studies have shown that a single dose of 120 mg ivermectin is safe and well tolerated. Based on the highest level of SARS-CoV-2 viral load in the first week of illness and the duration of severe disease, ivermectin 0.4 mg / kg body weight was used daily in our experiment for 5 days.

Border

Our research has limitations. The open-label design helps reduce adverse event reporting in the control group and further improves the effectiveness of ivermectin.

Our examine become now no longer designed to assess the results of ivermectin on Govit-19-precipitated death. Finally, the extent of our study may be determined in the adult study population, but young and healthy individuals at low risk for serious disease will benefit from some COVID-19 treatments. buy ivermectin

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