Safety and immunogenicity of anti-SARS CoV-2 conjugate vaccine SOBERANA 02 in a two-dose or three-dose heterologous scheme in adults: Phase IIb Clinical Trial

Background: We report results of immunogenicity, safety and reactogenicity of SOBERANA 02 in a two-dose or three-dose heterologous scheme in adults in a phase IIb clinical trial. Method: This phase IIb trial was designed as parallel, multicentre, adaptive, double blind, randomized and placebo-controlled. Subjects (N=810) aged 19-80 years were randomized to receive two doses of the recombinant SARS CoV-2 receptor binding domain (RBD) conjugated to tetanus toxoid (SOBERANA 02) and a third dose of dimeric RBD (SOBERANA Plus) 28 days apart; two production batches of active ingredient of SOBERANA 02 were evaluated. Primary outcome was the percentage of seroconverted subjects with ≥4-fold the anti-RBD IgG concentration. Secondary outcomes were safety, reactogenicity and neutralizing antibodies. Results: Seroconversion rate in vaccinees was respectively 76.3 and 96.8% after two or three doses, compared with 7.3% in placebo group. Anti-RBD IgG increased significantly after first and second dose of SOBERANA 02 respect to placebo group; and the third dose with SOBERANA Plus boosts the response compared to the second dose. Neutralizing IgG antibodies were detected against D614G and VOCs α, β and δ. Specific and functional antibodies were detected until 7-8 months after the third dose. The frequency of serious adverse events (AEs) associated with vaccination was very low (0.1%); with only one serious AE consistent with vaccination. Local pain was the most frequent AE. Conclusions: Two doses of SOBERANA 02 were well tolerated, safe an immunogenic in adults aged 19-80 years old. The heterologous combination with a third dose of SOBERANA Plus increased neutralizing antibodies, detectable 7-8 months after the third dose. Trial registry: https://rpcec.sld.cu/trials/RPCEC00000347

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Efficacy of Matricaria chamomilla L. in Infantile Colic: A Double Blind, Placebo Controlled Randomized Trial

Journal of Pharmaceutical Research International ◽

10.9734/jpri/2019/v31i630385 ◽

2020 ◽

pp. 1-11

Author(s):

Fatemeh Mohamadi Sorme ◽

Malihe Tabarra ◽

Hosein Alimadady ◽

Roja Rahimi ◽

Mahdi Sepidarkish ◽

...

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Infantile Colic ◽

Matricaria Chamomilla ◽

Double Blind ◽

Serious Adverse Event ◽

Double Blind Placebo ◽

Common Problems ◽

To Receive ◽

Delivery Type

Objective: Infantile colic is one of the most common problems in neonatal and early infancy, the prevalence of which has been reported as 10-20%. The present clinical trial was conducted to investigate whether topical use of chamomile oil reduces crying and fussing in breastfed colicky infants. Methods: A total of 102 breastfed colicky infants were divided into two groups to receive topical chamomile or placebo oil 6 times a day for 7 days. Both groups also received 5 mg of Simethicone syrup 4 times a day. Parents reported on crying and fussing duration, exertion times and side effects using a questionnaire. Results: 90 babies could complete the trial including 47 patients in chamomile group and 43 patients in the placebo group. Babies in both groups were the same in terms of gestational age, birth weight, birth order, gender, delivery type, crying and fussing on the day before the treatment. At the end of the study, crying and fussing was found to be lower in chamomile group than the placebo group (p <0.001). Also, 39 and 27 patients responded to the treatment in chamomile and placebo groups respectively. The effect of chamomile oil on crying (p<0.01) and fussing (p< 0.001) was significant. No serious adverse event was reported. Conclusion: Results revealed that chamomile oil reduced symptoms in breastfed colicky infants compared to the infants in the placebo group. This suggests that topical use of chamomile oil may be effective in the treatment of colic.

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Safety, tolerability, and immunogenicity of a SARS-CoV-2 recombinant spike protein vaccine: a randomised, double-blind, placebo-controlled, phase 1-2 clinical trial (ABDALA Study).

10.1101/2021.11.30.21267047 ◽

2021 ◽

Author(s):

Francisco Hernandez-Bernal ◽

Maria del Carmen Ricardo-Cobas ◽

Yenima Martin-Bauta ◽

Zadis Navarro-Rodriguez ◽

Marjoris Pinera-Martinez ◽

...

Keyword(s):

Placebo Group ◽

Neutralizing Antibodies ◽

Phase 1 ◽

Vaccination Schedule ◽

Phase 2 ◽

Igg Antibodies ◽

Protein Vaccine ◽

Double Blind ◽

Double Blind Placebo ◽

The Third

Aim: To evaluate the safety and immunogenicity of a SARS-CoV-2 recombinant spike protein vaccine (Abdala), administered intramuscularly in different strengths and vaccination schedules. Method: A phase 1-2, randomized, double-blind, placebo-controlled trial was done. Subjects were randomly distributed in 3 groups: placebo, 25 and 50 μg RBD. The product was applied intramuscularly, 0.5 mL in the deltoid region. During the first phase, two immunization schedules were studied: short (0-14-28 days) and long (0-28-56 days). In phase 2, only the short scheme was evaluated. The main endpoints were: safety and proportion of subjects with seroconversion of anti-RBD IgG antibodies to SARS-CoV-2. Blood samples were collected in several points according to the corresponding vaccination schedule to determine the level of RBD-specific IgG antibodies (seroconversion rates and geometric mean of the titers), the percentage of inhibition of RBD-ACE-2 binding and levels of neutralizing antibodies. Results: The product was well tolerated. Severe adverse events were not reported. Adverse reactions were minimal, mostly mild and local (from the injection site), resolved in the first 24-48 hours without medication. In phase 1, at day 56 (28 days after the third dose of the short vaccination schedule, 0-14-28 days) seroconversion of anti-RBD IgG was seen in 95.2 % of the participants (20/21) for the 50 μg group and 81 % of the participants (17/21) for the 25 μg group, and none in the placebo group (0/22); whereas neutralizing antibodies to SARS-CoV-2 were seen in 80 % of the participants (8/10) for the 50 μg group and 94.7% of the participants (18/19) for the 25 μg group. For the long schedule, at day 70 (14 days after the third dose) seroconversion of anti-RBD IgG was seen in 100% of the participants (21/21) for the 50 μg group and 94.7% of the participants (18/19) for the 25 μg group, and none in the placebo group (0/22); whereas neutralizing antibodies to SARS-CoV-2 were seen in 95 % of the participants (19/20) for the 50 μg group and 93.8% of the participants (15/16) for the 25 μg group In phase 2, at day 56 seroconversion of anti-RBD IgG was seen in 89.2% of the participants (214/240) for the 50 μg group, 77.7% of the participants (185/238) for the 25 μg group, and 4.6% in the placebo group (11/239); whereas neutralizing antibodies to SARS-CoV-2 were seen in 97.3% of the participants (146/150) for the 50 μg group and 95.1% of the participants (58/61) for the 25 μg group. Conclusion: Abdala vaccine against SARS-CoV-2 was safe, well tolerated and induced humoral immune responses against SARS-CoV-2 among adults from 19 to 80 years of age.

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The Effect of Dietary Supplementation of Crocetin for Myopia Control in Children: A Randomized Clinical Trial

Journal of Clinical Medicine ◽

10.3390/jcm8081179 ◽

2019 ◽

Vol 8 (8) ◽

pp. 1179 ◽

Cited By ~ 1

Author(s):

Kiwako Mori ◽

Hidemasa Torii ◽

Satoko Fujimoto ◽

Xiaoyan Jiang ◽

Shin-ichi Ikeda ◽

...

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Large Scale ◽

Suppressive Effect ◽

Institutional Review Boards ◽

Controlled Clinical Trial ◽

Myopia Progression ◽

Double Blind ◽

Institutional Review ◽

To Receive

The prevalence of myopia has been increasing in recent years. The natural carotenoid crocetin has been reported to suppress experimental myopia in mice. We evaluated the effects of crocetin on myopia suppression in children. A multicenter randomized double-blind placebo-controlled clinical trial was performed with 69 participants aged 6 to 12 years, whose cycloplegic spherical equivalent refractions (SER) were between −1.5 and −4.5 diopter (D). The participants were randomized to receive either a placebo or crocetin and followed up for 24 weeks. Axial length (AL) elongation and changes in SER were evaluated for 24 weeks. Both written informed assent from the participants and written informed consent from legal guardians were obtained in this study because the selection criteria of this trial included children aged between 6 and 12 years old. This trial was approved by the institutional review boards. A mixed-effects model was used for analysis, using both eyes. Two participants dropped out and 67 children completed this trial. The change in SER in the placebo group, −0.41 ± 0.05 D (mean ± standard deviation), was significantly more myopic compared to that in the crocetin group, −0.33 ± 0.05 D (p = 0.049). The AL elongation in the placebo group, 0.21 ± 0.02 mm, was significantly bigger than that in the crocetin group, 0.18 ± 0.02 mm (p = 0.046). In conclusion, dietary crocetin may have a suppressive effect on myopia progression in children, but large-scale studies are required in order to confirm this effect.

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Favipiravir In Adults with Moderate to Severe COVID-19: A Phase 3 Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial.

10.1101/2021.11.08.21265884 ◽

2021 ◽

Author(s):

Srinivas Shenoy ◽

Sagar Munjal ◽

Sarah Al Youha ◽

Mohammad Alghounaim ◽

Sulaiman Almazeedi ◽

...

Keyword(s):

Placebo Group ◽

Median Time ◽

Group Treatment ◽

Controlled Trial ◽

Clinical Status ◽

Phase 3 ◽

Serious Adverse Events ◽

Double Blind ◽

Clinical Risk ◽

To Receive

Aim: To assess the efficacy and safety of favipiravir in adults with moderate to severe coronavirus disease 2019 (COVID-19). Methods: In this randomized, double-blind, multicenter, phase 3 trial, adults (21 80 years) with real-time reverse transcriptase polymerase chain reaction (rRT-PCR) confirmed SARS CoV 2 infection and presenting with moderate to severe COVID-19 and requiring hospitalization were randomized 1:1 to oral favipiravir (day 1: 1800 mg BID and days 2-10: 800 mg BID) (FPV) plus standard supportive care (SoC) versus placebo plus SoC (placebo). The primary endpoint was time to resolution of hypoxia. Results: In total, 353 patients were randomized to receive either FPV or placebo (175 and 178 in the FPV and placebo groups, respectively). Overall, 76% of the patients (240/315, 78% in FPV vs. 75% in placebo group) reached resolution of hypoxia on or before day 28. The median time to resolution of hypoxia was 7 days in the FPV group and 8 days in the placebo group. Treatment effect was not significant [Hazard ratio (HR) (95% CI): 0.991 (0.767, 1.280) (p=0.94)]. Patients in the lower NEWS-2 clinical risk subgroup were more likely to achieve shorter time to resolution of hypoxia with the median time to resolution of hypoxia of 6 days in FPV and 7 days in placebo group [HR (95% CI): 1.21 (0.847, 1.731) (p=0.29)]; shorter time to hospital discharge with a median time to discharge of 8 and 10 days in the FPV and placebo group, respectively [HR (95% CI): 1.47 (1.081, 1.997) (p=0.014)]; and shorter time to improvement by 1-point improvement over baseline in WHO 10-point clinical status score with the median time to improvement by 1-point from baseline of 6 and 7 days in the FPV and placebo group, respectively [HR (95% CI): 1.16 (0.830, 1.624) (p=0.38)] than higher NEWS-2 clinical risk subgroup. Treatment emergent adverse event (TEAEs) were experienced by 62/334 (19%) patients [35/168 (21%) patients in FPV and 27/166 (16%) in placebo group]. Hyperuricaemia/increased blood uric acid was reported in 9 (3%)/2 (1%) patients [8 (5%)/1(1%) patients in FPV and 1 (1%)/1(1%) in placebo group] ,which were of mild intensity and transient. Overall, 36 serious adverse events (SAEs) were reported, 20 in FPV and 16 in placebo group. Conclusion: The trial did not find favipiravir to be effective in moderate to severe, hospitalized COVID-19 patients; favourable clinical trends were observed in patients with lower NEWS-2 risk when early administration of favipiravir could be achieved.

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Value of Whole-Body Washing With Chlorhexidine for the Eradication of Methicillin-ResistantStaphylococcus aureus:A Randomized, Placebo-Controlled, Double-Blind Clinical Trial

Infection Control and Hospital Epidemiology ◽

10.1086/519929 ◽

2007 ◽

Vol 28 (9) ◽

pp. 1036-1043 ◽

Cited By ~ 88

Author(s):

C. Wendt ◽

S. Schinke ◽

M. Württemberger ◽

K. Oberdorfer ◽

O. Bock-Hensley ◽

...

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Treatment Group ◽

Solution Treatment ◽

University Hospital ◽

Whole Body ◽

Double Blind ◽

Antiseptic Solution ◽

Double Blind Clinical Trial ◽

Double Blinded

Background.Whole-body washing with antiseptic solution has been widely used as part of eradication treatment for colonization with methicillin-resistantStaphylococcus aureus(MRSA), but evidence for the effectiveness of this measure is limited.Objective.To study the efficacy of whole-body washing with chlorhexidine for the control of MRSA.Design.Randomized, placebo-controlled, double-blinded clinical trial.Setting.University Hospital of Heidelberg and surrounding nursing homes.Patients.MRSA carriers who were not treated concurrently with antibiotics effective against MRSA were eligible for the study.Intervention.Five days of whole-body washing with either 4% chlorhexidine solution (treatment group) or with a placebo solution. All patients received mupirocin nasal ointment and chlorhexidine mouth rinse. The outcome was evaluated 3, 4, 5, 9, and 30 days after treatment with swab samples taken from several body sites.Results.Of 114 patients enrolled in the study (56 in the treatment group and 58 in the placebo group), 11 did not finish treatment (8 from the treatment group and 3 from the placebo group [P= .02]). At baseline, the groups did not differ with regard to age, sex, underlying condition, site of MRSA colonization, or history of MRSA eradication treatment. Eleven patients were MRSA-free 30 days after treatment (4 from the treatment group and 7 from the placebo group [P= .47]). Only groin-area colonization was significantly better eradicated by the use of chlorhexidine. The best predictor for total eradication was a low number of body sites positive for MRSA. Adverse effects were significantly more frequent in the treatment group than in the placebo group (any symptom, 71% vs 33%) but were reversible in most cases.Conclusion.Whole-body washing can reduce skin colonization, but it appears necessary to extend eradication measures to the gastrointestinal tract, wounds, and/or other colonized body sites if complete eradication is the goal.Trial Registration.ClinicalTrials.gov identifier: NCT00266448.

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Adverse events and blinding in two randomized trials of hyperbaric oxygen for persistent post-concussive symptoms

Undersea and Hyperbaric Medicine ◽

10.22462/13.15.2019.10 ◽

2019 ◽

pp. 331-340

Author(s):

Susan Churchill ◽

◽

Kayla Deru ◽

Lindell K. Weaver ◽

Steffanie H. Wilson ◽

...

Keyword(s):

Clinical Trials ◽

Adverse Events ◽

Hyperbaric Oxygen ◽

Gas Flow ◽

Randomized Trials ◽

Symptom Improvement ◽

Sham Control ◽

Serious Adverse Events ◽

Double Blind ◽

To Receive

Safety monitoring and successful blinding are important features of randomized, blinded clinical trials. We report chamber- and protocol-related adverse events (AEs) for participants enrolled in two randomized, double-blind clinical trials of hyperbaric oxygen (HBO2) for persistent post-concussive symptoms clinicaltrials.gov identifiers NCT01306968, HOPPS, and NCT01611194, BIMA), as well as the success of maintaining the blind with a low-pressure sham control arm. In both studies, participants were randomized to receive HBO2 (1.5 atmospheres absolute, >99% oxygen) or sham chamber sessions (1.2 atmospheres absolute, room air). In 143 participants undergoing 4,245 chamber sessions, chamber-related adverse events were rare (1.1% in the HOPPS study, 2.2% in the BIMA study). Minor, non-limiting barotrauma was the most frequently reported. Rarely, some participants experienced headache with chamber sessions. No serious adverse events were associated with chamber sessions. An allocation questionnaire completed after intervention revealed that the sham control arm adequately protected the blind in both trials. Participants based allocation assumptions on symptom improvement or lack of symptom improvement and could not discern intervention arm by pressure, smell, taste, or gas flow.

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Solumedrol Treatment for Severe Sepsis in Humans with a Blunted Adrenocorticotropic Hormone-Cortisol Response: A Prospective Randomized Double-Blind Placebo-Controlled Pilot Clinical Trial

Journal of Intensive Care Medicine ◽

10.1177/08850666211038883 ◽

2021 ◽

pp. 088506662110388

Author(s):

Divya Birudaraju ◽

Sajad Hamal ◽

John A. Tayek

Keyword(s):

Blood Pressure ◽

Clinical Trial ◽

Adrenocorticotropic Hormone ◽

Serum Cortisol ◽

High Dose ◽

Cortisol Response ◽

Acth Stimulation ◽

Double Blind ◽

Significant Difference ◽

To Receive

Purpose To test the benefits of Solumedrol treatment in sepsis patients with a blunted adrenocorticotropic hormone (ACTH)-cortisol response (delta <13 µg/dL) with regard to the number of days on ventilator, days on intravenous blood pressure support, length of time in an intensive care unit (ICU), 14-day mortality, and 28-day mortality. The trial was prospective, randomized, and double-blind. As part of a larger sepsis trial, 54 patients with sepsis had an intravenous ACTH stimulation test using 250 µg of ACTH, and serum cortisol was measured at times 0, 30, and 60 min. Eleven patients failed to increase their cortisol concentration above 19.9 µg/dL and were excluded from the clinical trial as they were considered to have adrenal insufficiency. The remaining 43 patients had a baseline cortisol of 32 ± 1 µg/dL increased to 38 ± 3 µg/dL at 30 min and 40 ± 3 at 60 min. All cortisol responses were <12.9 µg/dL between time 0 and time 60, which is defined as a blunted cortisol response to intravenous ACTH administration. Twenty-one were randomized to receive 20 mg of intravenous Solumedrol and 22 were randomized to receive a matching placebo every 8 h for 7-days. There was no significant difference between the two randomized groups. Data analysis was carried out bya two-tailed test and P < .05 as significant. Results Results: The mean age was 51 ± 2 (mean ± SEM) with 61% female. Groups were well matched with regard to APACHE III score in Solumedrol versus placebo (59 ± 6 vs 59 ± 6), white blood cell count (18.8 ± 2.2 vs 18.6 ± 2.6), and incidence of bacteremia (29 vs 39%). The 28-day mortality rate was reduced in the Solumedrol treated arm (43 ± 11 vs 73 ± 10%; P < .05). There was no change in days in ICU, days on blood pressure agents, or days on ventilator. Seven days of high-dose intravenous Solumedrol treatment (20 mg every 8 h) in patients with a blunted cortisol response to ACTH was associated with an improved 28-day survival. This small study suggests that an inability to increase endogenous cortisol production in patients with sepsis who are then provided steroid treatment could improve survival.

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Subcutaneous granulocyte colony-stimulating factor administration for subacute traumatic spinal cord injuries, report of neurological and functional outcomes: a double-blind randomized controlled clinical trial

Journal of Neurosurgery Spine ◽

10.3171/2018.6.spine18209 ◽

2019 ◽

Vol 30 (1) ◽

pp. 19-30 ◽

Cited By ~ 4

Author(s):

Nazi Derakhshanrad ◽

Hooshang Saberi ◽

Mir Saeed Yekaninejad ◽

Mohammad Taghi Joghataei

Keyword(s):

Clinical Trial ◽

Spinal Cord ◽

Placebo Group ◽

Spinal Cord Injuries ◽

Functional Improvement ◽

Granulocyte Colony Stimulating Factor ◽

Double Blind ◽

Cord Injury ◽

The Mean ◽

Stimulating Factor

OBJECTIVEGranulocyte-colony stimulating factor (G-CSF) is a major cytokine that has already been clinically verified for chronic traumatic spinal cord injuries (TSCIs). In this study, the authors set out to determine the safety and efficacy of G-CSF administration for neurological and functional improvement in subacute, incomplete TSCI.METHODSThis phase II/III, prospective, double-blind, placebo-controlled, parallel randomized clinical trial was performed in 60 eligible patients (30 treatment, 30 placebo). Patients with incomplete subacute TSCIs with American Spinal Injury Association Impairment Scale (AIS) grades B, C, and D were enrolled. Patients were assessed using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) scale, Spinal Cord Independence Measure (SCIM-III) and International Association of Neurorestoratology Spinal Cord Injury Functional Rating Scale (IANR-SCIFRS), just before intervention and at 1, 3, and 6 months, after 7 daily subcutaneous administrations of 300 μg/day of G-CSF in the treatment group and placebo in the control group.RESULTSAmong 60 participants, 28 patients (93.3%) in the G-CSF group and 26 patients (86.6%) in the placebo group completed the study protocol. After 6 months of follow-up, the AIS grade remained unchanged in the placebo group, while in the G-CSF group 5 patients (45.5%) improved from AIS grade B to C, 5 (45.5%) improved from AIS grade C to grade D, and 1 patient (16.7%) improved from AIS grade D to E. The mean ± SEM change in ISNCSCI motor score in the G-CSF group was 14.9 ± 2.6 points, which was significantly greater than in the placebo group (1.4 ± 0.34 points, p < 0.001). The mean ± SEM light-touch and pinprick sensory scores improved by 8.8 ± 1.9 and 10.7 ± 2.6 points in the G-CSF group, while those in the placebo group improved by 2.5 ± 0.60 and 1.2 ± 0.40 points, (p = 0.005 and 0.002, respectively). Evaluation of functional improvement according to the IANR-SCIFRS instrument revealed significantly more functional improvement in the G-CSF group (10.3 ± 1.3 points than in the placebo group (3.0 ± 0.81 points; p < 0.001). A significant difference was also observed between the 2 groups as measured by the SCIM-III instrument (29.6 ± 4.1 vs 10.3 ± 2.2, p < 0.001).CONCLUSIONSIncomplete subacute TSCI is associated with significant motor, sensory, and functional improvement after administration of G-CSF.Clinical trial registration no.: IRCT201407177441N3 (www.irct.ir)

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Efficacy of a nasal spray containing Iota-Carrageenan in the prophylaxis of COVID-19 in hospital personnel dedicated to patients care with COVID-19 disease. A pragmatic multicenter, randomized, double-blind, placebo-controlled trial (CARR-COV-02)

10.1101/2021.04.13.21255409 ◽

2021 ◽

Author(s):

Juan Manuel Figueroa ◽

Monica Lombardo ◽

Ariel Dogliotti ◽

Luis Flynn ◽

Robert P. Giugliano ◽

...

Keyword(s):

Placebo Group ◽

Nasal Spray ◽

Controlled Trial ◽

Hospital Personnel ◽

Culture Methods ◽

Double Blind ◽

Double Blind Placebo ◽

Significant Efficacy ◽

To Receive

Background Iota-Carrageenan (I-C) is a sulfate polysaccharide synthesized by red algae, with demonstrated antiviral activity and clinical efficacy as nasal spray in the treatment of common cold. In vitro, I-C inhibits SARS-CoV-2 infection in cell culture. Methods This is a pragmatic multicenter, randomized, double-blind, placebo-controlled trial assessing the use of a nasal spray containing I-C in the prophylaxis of COVID-19 in hospital personnel dedicated to care of COVID-19 patients. Clinically healthy physicians, nurses, kinesiologists and others medical providers were assigned in a 1:1 ratio to receive four daily doses of I-C spray or placebo for 21 days. The primary end point was clinical COVID-19, as confirmed by reverse-transcriptase-polymerase-chain-reaction testing, over a period of 21 days. The trial is registered at ClinicalTrials.gov (NCT04521322). Findings A total of 394 individuals were randomly assigned to receive I-C or placebo. Both treatment groups had similar baseline characteristics. The incidence of COVID-19 was significantly lower in the I-C group compared to placebo (1.0% vs 5.0%) (Odds Ratio 0.19 (95% confidence interval 0.05 to 0.77; p= 0.03). Workday loss in placebo group compared to I-C were 1.6% days / person (95% CI, 1.0 to 2.2); p <0.0001 There were no differences in the incidence of adverse events across the two groups (17.3% in the I-C group and 15.2% in the placebo group, p= 0.5). Interpretation I-C showed significant efficacy in preventing SARS-CoV-2 infection in hospital personnel dedicated to care patients with COVID-19 disease.

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The efficacy of trimethoprim-sulfamethoxazole treatment in children with acute bloody diarrhea

Paediatrica Indonesiana ◽

10.14238/pi47.1.2007.17-20 ◽

2007 ◽

Vol 47 (1) ◽

pp. 17

Author(s):

Selvi Nafianti ◽

Oke R. Ramayani ◽

Dedy G. Daulay ◽

Supriatmo Supriatmo ◽

Berlian Hasibuan ◽

...

Keyword(s):

Clinical Trial ◽

Developing Countries ◽

Placebo Group ◽

Campylobacter Jejuni ◽

Bloody Diarrhea ◽

Fecal Analysis ◽

Double Blind ◽

Double Blind Clinical Trial ◽

Stool Analysis

Background The etiologies of bloody diarrhea are shigella,amoeba, enterocolitis, trichuriasis, and other causes i.e, EIEC,Campylobacter jejuni or rotavirus. In developing countries,trimetroprim-sulfamethoxazole (TMP-SMP) is effective in 80%of children with bloody diarrhea.Objective To determine the efficacy of trimethoprim-sulfa-methoxazole (TMP-SMX) treatment in children with acute bloodydiarrhea.Methods A randomized double blind clinical trial was conductedin Adam Malik Hospital and Dr. Pirngadi Hospital Medan duringSeptember 2003-March 2004. Children aged 2-24 months oldwith diagnosis of acute bloody diarrhea were randomized into twogroups to either receive TMP-SMX or placebo for 5 days.Microscopic fecal analysis was performed on the first, second,fifth and twelfth day, and the results were compared.Results A total of 68 children consisted of 48 (71%) boys and 20(29%) girls were enrolled. Each group had 34 participants.Analysis of the first day showed leukocyte and erythrocyte in thestool specimens, which were all absent on the twelfth day in bothgroups. There was no difference in stool analysis between TMP-SMX and placebo group in day two (P=0.758), day five (P=0.341)and day twelve. Diarrhea duration in TMP-SMX and placebogroup was 7.18 days and 6.65 days, respectively. This differentwas statistically not significant (P=0.385).Conclusion There is no difference in the efficacy of trimethoprim-sulfamethoxazole treatment compared to placebo in children withacute bloody diarrhea.

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