BACKGROUND: No effective oral therapy exists for early coronavirus disease 2019 (COVID-19). OBJECTIVE: To investigate whether hydroxychloroquine could reduce COVID-19 severity in adult outpatients. DESIGN: Randomized, double-blind, placebo-controlled trial conducted from 22 March through 20 May 2020. (ClinicalTrials.gov: NCT04308668). SETTING: Internet-based trial across the United States and Canada (40 states and 3 provinces). PARTICIPANTS: Symptomatic, nonhospitalized adults with laboratory-confirmed COVID-19 or probable COVID-19 and high-risk exposure within 4 days of symptom onset. INTERVENTION: Oral hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 more days) or masked placebo. MEASUREMENTS: Symptoms and severity at baseline and then at days 3, 5, 10, and 14 using a 10-point visual analogue scale. The primary end point was change in overall symptom severity over 14 days. RESULTS: Of 491 patients randomly assigned to a group, 423 contributed primary end point data. Of these, 341 (81%) had laboratory-confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or epidemiologically linked exposure to a person with laboratory-confirmed infection; 56% (236 of 423) were enrolled within 1 day of symptoms starting. Change in symptom severity over 14 days did not differ between the hydroxychloroquine and placebo groups (difference in symptom severity: relative, 12%; absolute, -0.27 point [95% CI, -0.61 to 0.07 point]; P = 0.117). At 14 days, 24% (49 of 201) of participants receiving hydroxychloroquine had ongoing symptoms compared with 30% (59 of 194) receiving placebo (P = 0.21). Medication adverse effects occurred in 43% (92 of 212) of participants receiving hydroxychloroquine versus 22% (46 of 211) receiving placebo (P < 0.001). With placebo, 10 hospitalizations occurred (2 non-COVID-19-related), including 1 hospitalized death. With hydroxychloroquine, 4 hospitalizations occurred plus 1 nonhospitalized death (P = 0.29). LIMITATION: Only 58% of participants received SARS-CoV-2 testing because of severe U.S. testing shortages. CONCLUSION: Hydroxychloroquine did not substantially reduce symptom severity in outpatients with early, mild COVID-19. PRIMARY FUNDING SOURCE: Private donors.

/pdf/hydroxychloroquine-in-nonhospitalized-adults-with-early-29qp4nhwvy.pdf

Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19 : A Randomized Trial.

There is no known effective oral therapy for early COVID-19. This randomized trial evaluated effects of oral hydroxychloroquine on symptoms and disease severity in adult outpatients with early COVI...

Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19.

Objective S-Adenosylmethionine (SAM) and S-adenosylhomocysteine (SAH) are indicators of global transmethylation and may play an important role as markers of severity of COVID-19. Methods The levels of plasma SAM and SAH were determined in patients admitted with COVID-19 (n = 56, mean age = 61). Lung injury was identified by computed tomography (CT) in accordance with the CT0-4 classification. Results SAM was found to be a potential marker of lung damage risk in COVID-19 patients (SAM > 80 nM; CT3,4 vs. CT 0-2: relative ratio (RR) was 3.0; p = 0.0029). SAM/SAH > 6.0 was also found to be a marker of lung injury (CT2-4 vs. CT0,1: RR = 3.47, p = 0.0004). Interleukin-6 (IL-6) levels were associated with SAM (ρ = 0.44, p = 0.01) and SAH (ρ = 0.534, p = 0.001) levels. Conclusions High SAM levels and high methylation index are associated with the risk of lung injury in COVID-19 patients. The association of SAM and SAH with IL-6 indicates an important role of transmethylation in the development of cytokine imbalance in COVID-19 cases.

/pdf/plasma-s-adenosylmethionine-is-associated-with-lung-injury-43hjeuhpmz.pdf

Plasma S-Adenosylmethionine is Associated with Lung Injury in COVID-19

Folic acid as placebo in controlled clinical trials of hydroxychloroquine prophylaxis in COVID-19: Is it scientifically justifiable?

<h3></h3> Представлено биохимическое обоснование выбора гомоцистеина как значимого маркера прогноза течения коронавирусной инфекции. Клиническими исследованиями подтверждена гипергомоцистеинемия у больных с COVID-19 и показана зависимость течения болезни, развития осложнений и неблагоприятного исхода от уровня гомоцистеина в крови. Выявлен клинический эффект при включении в комплексную терапию фолиевой кислоты и других витаминов группы В. 

Homocysteine as a predictor of the severity of coronavirus infection: biochemical justification

On March 11, 2020, the WHO announced the COVID-19 outbreak a pandemic The disease was established to be caused by a new singlestranded RNA virus (ss-RNA, 29903 bp) that belongs to a group of coronaviruses (CoV) Objective : to assess the results of a pilot analysis of the efficiency of using Angiovit in the combination treatment of acute COVID-19 with pneumonia or acute respiratory viral infection Patients and methods  The study enrolled 50 patients with acute COVID-19 In all the patients, the diagnosis of coronavirus infection was confirmed by polymerase chain reaction Angiovit was used in 25 patients (13 (52%) women) (mean age, 394 years) with moderate infection who had been admitted on an average of disease day 3 (a study group) A comparison group consisted of 25 patients whose gender, age, and clinical features of COVID-19 did not differ at the time of admission; they were prescribed only mainstay therapy Results and discussion  Adding Angiovit to the mainstay therapy contributed to an average reduction in the fever period from 588 to 412 days (p<005) and to the earlier hospital discharge of patients with an improvement (on day 13 versus on day 168 days in the comparison group; p<005); Normalization of CRP, D-dimer, and homocysteine levels occurred considerably and faster Conclusion  The pilot study has shown that the use of Angiovit in the combination therapy of COVID-19 reduces the clinical and laboratory manifestations of inflammation and hypercoagulation, which may also be associated with the action of folic acid

/pdf/the-first-experience-with-angiovit-in-the-combination-2wh628ldym.pdf

The first experience with Angiovit in the combination treatment of acute COVID-19 infection

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The first experience with Angiovit in the combination treatment of acute COVID-19 infection