ABSTRACT
AIM: The search for etiopathogenetic agents to prevent the development of severe and extremely severe COVID-19 remains relevant. A placebo-controlled randomized clinical trial was conducted to evaluate the efficacy and safety of the antibody-based biological drug (Raphamin). MATERIALS AND METHODS: 785 outpatients 18-75 y.o. with laboratory confirmed mild COVID-19 were included within 24 hours from the disease onset. 771 patients were randomized to the group Raphamin (n=382) and the Placebo group (n=389). The study drug/placebo was prescribed for 5 days. The rate of progression to a more severe degree of COVID-19 by day 28 as well as the time to sustained clinical recovery and the frequency of hospitalization were evaluated. Safety was assessed taking into account adverse events, vital signs and laboratory parameters. RESULTS: The number of cases of progression to a more severe degree of COVID-19 in participants receiving Raphamin was 59 (15.5%) [52 (14.6%)] versus placebo - 89 (22.9%) [85 (23.7%)], ITT and [PP] analysis data are presented. The odds ratio between groups was OR=0.6157 [OR=0.5494], 95% confidence interval 0.4276-0.8866 [0.3750-0.8048], which meant a reduction in the chance of progression to a more severe degree by 38.4% [45.1%] or 1.48 [1.62] times; p=0.0088 [p=0.0019]. The time to sustained recovery in the Raphamin group was 4.5±2.4 [4.6±2.4] days, versus placebo - 5.8±4.7 [6.0±4.8] days; p=0.0025 [p=0.0036]. No adverse events with a certain relationship were registered. CONCLUSION: Raphamin reduces the risk of progression to a more severe degree of the COVID-19 and significantly shortens the duration of clinical symptoms.
Subject(s)
COVID-19 , Humans , SARS-CoV-2 , Treatment Outcome , Hospitalization , Double-Blind MethodABSTRACT
AIM: To evaluate the efficacy and safety of Raphamin, containing technologically processed affinity-purified antibodies to interferon , CD4 receptor, 1 domain of the major histocompatibility complex class II and 2 microglobulin major histocompatibility complex class I in the treatment of acute respiratory viral infection (ARVI), including influenza, in adults. MATERIALS AND METHODS: 240 patients 1870 years old with ARVI were included in a phase III (20192020), randomized, double-blind, placebo-controlled trial. Pregnant women, patients with suspected bacterial infections were excluded from the study. Raphamin/placebo was prescribed for 5 days within 24 hours of the illness onset. Primary endpoint was a time to resolution of ARVI (Polymerase chain reaction PCR-confirmed). Additionally, the severity of ARVI, proportion of patients with ARVI resolution/worsening/complications, frequency of antipyretics prescription, and time to resolution of symptoms of ARVI (including PCR non confirmed) were assessed. RESULTS: The average time to resolution of ARVI (PCR-confirmed) was 4.11.9 [4.01.9] and 5.02.5 [5.02.5] days in the Raphamin/placebo groups (ITT and [PP] analysis, Ñ=0.0155 and [Ñ=0.0114], respectively). The duration of ARVI decreased by 0.892.23 [0.932.25] days. Superiority of Raphamin was shown during therapy period according to the ARVI resolution criterion (Ñ=0.0014 [Ñ=0.0005]). There were no statistically significant difference in the severity of ARVI and frequency of antipyretics prescription. The proportion of patients with worsening/complications was 0 [0]% and 2.5 [2.8]% in the Raphamin and placebo groups, respectively. Favorable safety profile of Raphamin (including the incidence and severity of adverse events) and high compliance were shown. CONCLUSION: Raphamin promotes significant decrease, practically by a day, the duration of ARVI, including influenza.
Subject(s)
Antipyretics , Influenza, Human , Respiratory Tract Infections , Virus Diseases , Adult , Humans , Female , Pregnancy , Antiviral Agents/adverse effects , Influenza, Human/drug therapy , Influenza, Human/epidemiology , Antipyretics/therapeutic use , CD4 Antigens/therapeutic use , Virus Diseases/drug therapy , Respiratory Tract Infections/drug therapy , Respiratory Tract Infections/epidemiology , Double-Blind Method , Antibodies , Interferons/therapeutic use , Treatment OutcomeABSTRACT
The study has shown the efficiency of a competitive ELISA (C-ELISA) variant or an indirect ELISA (I-ELUSA) in the detection of antibodies to swine vesicular disease virus (SVDV) versus traditional assays, such as a microneutralization test, a blocking ELIDA test, and a the reference test Ceditest SVDV (Cedi-Diagnostics B.V., Netherlands). Specific antibodies in the pig sera could be detected by C-ELISA on days 4-5 and by I-ELISA on day 6 after experimental SVDV infection. Specific antibodies were detected in a contact pig 11 days after the beginning of the experiment.
Subject(s)
Antibodies, Viral/blood , Enterovirus B, Human/isolation & purification , Enzyme-Linked Immunosorbent Assay , Fluorescent Antibody Technique, Direct , Fluorescent Antibody Technique, Indirect , Swine Vesicular Disease/diagnosis , Animals , Enterovirus B, Human/immunology , Swine , Swine Vesicular Disease/bloodABSTRACT
Perspectives for nature protection and energy-saving, by using blue-green algae, are discussed. Utilization of their phyto biomass for biogas manufacture will lead to the environmental normalization of the Transdniestria and allow one to have about 19,000,000 m3 of methane only from the water area of only one Kremenchug water basin each vegetative period (70 days).
Subject(s)
Biofuels , Bioreactors , Biotechnology/methods , Cyanobacteria , Humans , PhotosynthesisSubject(s)
Immunoglobulins, Intravenous/therapeutic use , Immunologic Deficiency Syndromes/drug therapy , Immunologic Factors/therapeutic use , Infections/drug therapy , Humans , Immunoglobulins, Intravenous/adverse effects , Immunoglobulins, Intravenous/blood , Immunologic Factors/adverse effects , Immunologic Factors/blood , Infections/immunology , Metabolic Clearance Rate , Treatment OutcomeABSTRACT
The site-specific endonuclease AbaI was isolated and purified to functional purity from the soil nitrogen-fixing bacterium Azospirillum brasilense UQ 1796. Purification included successive chromatography on columns with phosphocellulose, heparin-Sepharose, and hydroxyapatite. The purified enzyme recognizes the palindromic DNA sequence 5'-T decreases ATCA-3' and cleaves it as shown by the arrow. The isolated enzyme belongs to class II restriction endonuclease and is an isoschizomer of endonuclease BclI. The enzyme of AbaI is active at 26-56 degrees C. The optimal temperature is 48 degrees C and the optimal buffer is LRB.