Clinical trials

Last updated: 2022 Aug 26
Total hit(s): 141
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3 patients (1%) in the sotrovimab group had illness progression resulting to hospitalisation or death, compared to 21 patients (7%) in the placebo group. Five patients in the placebo group were admitted to the intensive care unit, one of whom died on day 29.Sotrovimab lowered the probability of disease progression in high-risk patients with mild-to-moderate Covid-19.
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 		34706189
(N Engl J Med)
PMID
34706189
Date of Publishing: 2021 Nov 18
Title Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab
Author(s) nameGupta A, Gonzalez-Rojas Y et al.
Journal N Engl J Med
Impact factor
37.91
Citation count: 135
Date of Entry 2022 Aug 26

In total, 868 patients were evaluated for safety (430 in the sotrovimab group and 438 in the placebo group). Patients in the sotrovimab group reported 17% of adverse events, whereas those in the placebo group reported 19%; major adverse events were less likely with sotrovimab than with placebo (in 2% and 6% of the patients, respectively).
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 		34706189
(N Engl J Med)
PMID
34706189
Date of Publishing: 2021 Nov 18
Title Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab
Author(s) nameGupta A, Gonzalez-Rojas Y et al.
Journal N Engl J Med
Impact factor
37.91
Citation count: 135
Date of Entry 2022 Aug 26

Hospitalizations made up 87% of the events with the composite primary outcome. The results for the main outcome were identical in the modified intention-to-treat analysis, but they were higher in the per-protocol analysis. In the primary intention-to-treat analysis, there were 17 deaths in the fluvoxamine group and 25 deaths in the placebo group. In the population that followed the protocol, there was one death in the fluvoxamine group and twelve in the placebo group. There is no accepted standard of care for the early management of COVID-19, and numerous advocacy organisations support various therapies, some of which were examined in this study and our earlier trials.
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 		34717820
(Lancet Glob Health)
PMID
34717820
Date of Publishing: 2021 Oct 27
Title Effect of early treatment with fluvoxamine on risk of emergency care and hospitalisation among patients with COVID-19: the TOGETHER randomised, platform clinical trial
Author(s) nameReis G, Dos Santos Moreira-Silva EA et al.
Journal Lancet Glob Health
Impact factor
16.37
Citation count: 55
Date of Entry 2022 Aug 26

Ocrelizumab-treated MS patients in exhibited reduced antibody responses after vaccination and produced SARS-CoV-2-specific T-cell responses as compared to those of healthy controls.
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 		34554197
(JAMA Neurol)
PMID
34554197
Date of Publishing: 2021 Sep 23
Title Humoral and T-Cell Response to SARS-CoV-2 Vaccination in Patients With Multiple Sclerosis Treated With Ocrelizumab
Author(s) nameBrill L, Rechtman A et al.
Journal JAMA Neurol
Impact factor
33.6
Citation count: 32
Date of Entry 2022 Aug 26

Infliximab-treated individuals had lower seroprevalence than vedolizumab-treated patients (3.4% (161/4685) vs. 6.0% (134/2250). Infliximab and immunomodulator use were both linked to reduced seropositivity, according to multivariable logistic regression analysis. Seroconversion was detected in fewer infliximab-treated individuals (48% (39/81) vs 83% (30/36) in patients with proven SARS-CoV-2 infection, and the amplitude of anti-SARS-CoV-2 reactivity was lower (median 0.8 cut-off index (0.2-5.6) vs 37.0). (15.2-76.1).
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 		33753421
(Gut)
PMID
33753421
Date of Publishing: 2021 May
Title Anti-SARS-CoV-2 antibody responses are attenuated in patients with IBD treated with infliximab
Author(s) nameKennedy NA, Goodhand JR et al.
Journal Gut
Impact factor
15.78
Citation count: 56
Date of Entry 2022 Aug 26

Patients who received dexamethasone had an average of 6.6 ventilator-free days during the first 28 days compared to 4.0 in the standard care group. Patients in the dexamethasone group had an average SOFA score of 6.1 at 7 days compared to 7.5 in the conventional treatment group. The predetermined secondary outcomes of all-cause death at 28 days, ICU-free days during the first 28 days, mechanical ventilation duration at 28 days, and the 6-point ordinal scale at 15 days did not differ significantly from one another.
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 		32876695
(JAMA)
PMID
32876695
Date of Publishing: 2020 Oct 6
Title Effect of Dexamethasone on Days Alive and Ventilator-Free in Patients With Moderate or Severe Acute Respiratory Distress Syndrome and COVID-19: The CoDEX Randomized Clinical Trial
Author(s) nameTomazini BM, Maia IS et al.
Journal JAMA
Impact factor
14.78
Citation count: 448
Date of Entry 2022 Aug 26

Secondary infections were experienced by 33 patients (21.9%) in the dexamethasone group compared to 43 patients (29.1%) in the standard care group. In addition, 47 patients (31.1%) compared to 42 patients (28.3%) required insulin for glucose control, and 5 patients (3.3%) compared to 9 patients (6.1%) experienced other serious adverse events.
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 		32876695
(JAMA)
PMID
32876695
Date of Publishing: 2020 Oct 6
Title Effect of Dexamethasone on Days Alive and Ventilator-Free in Patients With Moderate or Severe Acute Respiratory Distress Syndrome and COVID-19: The CoDEX Randomized Clinical Trial
Author(s) nameTomazini BM, Maia IS et al.
Journal JAMA
Impact factor
14.78
Citation count: 448
Date of Entry 2022 Aug 26

The 2 patients did not require hospitalization. At 7 and 9 weeks after infection, the man had negative serology results. At six and twelve weeks after infection, the woman had negative serology results. To definitively assess whether specific DMTs may reduce SARS-CoV-2 antibody generation and whether this may raise the risk of re-infection in MS patients, large trials are required.
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 		32622338
(Mult Scler Relat Disord)
PMID
32622338
Date of Publishing: 2020 Sep
Title Negative SARS-CoV-2 antibody testing following COVID-19 infection in Two MS patients treated with ocrelizumab
Author(s) name Thornton JR, Harel A.
Journal Mult Scler Relat Disord
Impact factor
2.64
Citation count: 41
Date of Entry 2022 Aug 26

The results of this trial indicate that a brief course of MP in hospitalised COVID-19 patients did not lower mortality overall. At Day 28, there was no difference in the fatality rates across the groups. According to a subgroup analysis, the MP group's patients over 60 had a decreased mortality rate at Day 28. Patients in the MP arm typically required greater insulin therapy, and viral clearance in respiratory secretion was not different until Day 7.
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 		32785710
(Clin Infect Dis)
PMID
32785710
Date of Publishing: 2020 Aug 12
Title Methylprednisolone as Adjunctive Therapy for Patients Hospitalized With Coronavirus Disease 2019 (COVID-19; Metcovid): A Randomized, Double-blind, Phase IIb, Placebo-controlled Trial
Author(s) nameJeronimo CMP, Farias MEL et al.
Journal Clin Infect Dis
Impact factor
7.71
Citation count: 192
Date of Entry 2022 Aug 26

Administration of intravenous tocilizumab improved fever, chest pain, and abdominal pain within 24 hours. Patient showed more than a 10-fold increase in level of IL-6, 48 hours after administration of tocilizumab. Rise in IL-6 levels is sometimes an indicator of COVID-19 severity. The increase in IL-6 levels after administration is attributed to increased availability of IL-6, due to less binding to the IL-6 receptor.
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 		32359210
(Am J Transplant)
PMID
32359210
Date of Publishing: 2020 Aug
Title Clinical course of COVID-19 in a liver transplant recipient on hemodialysis and response to tocilizumab therapy: A case report
Author(s) nameHammami MB, Garibaldi B et al.
Journal Am J Transplant
Impact factor
6.26
Citation count: 24
Date of Entry 2022 Aug 26

All patients were receiving high-flow supplementary oxygen at the time of baseline, and the majority (78% of TCZ patients and 61% of patients receiving standard care) were receiving non-invasive ventilation. In comparison to 61% of patients receiving conventional treatment over the 28-day follow-up, 69% of TCZ patients showed clinical improvement. Death rates were 15% in the tocilizumab group and 33% in the group receiving standard care (p = 0.15). In the TCZ group, higher baseline PaO2:FiO2 was a predictor of clinical improvement at day 28, but older age was a predictor of death. Both groups experienced a similar level of infection and pulmonary thrombosis.
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 		32482597
(Eur J Intern Med)
PMID
32482597
Date of Publishing: 2020 Jun
Title Efficacy and safety of tocilizumab in severe COVID-19 patients: a single-centre retrospective cohort study
Author(s) nameCampochiaro C, Della-Torre E et al.
Journal Eur J Intern Med
Impact factor
3.05
Citation count: 208
Date of Entry 2022 Aug 26

All patients were on high-flow supplemental oxygen at the start of the study, and the majority (78% of TCZ patients and 61% of standard care patients) were on non-invasive ventilation. 69% of TCZ patients improved clinically during the 28-day follow-up, compared to 61% of conventional treatment patients. The tocilizumab group had a 15% mortality rate, while the conventional treatment group had a 33% mortality rate. Infection and pulmonary thrombosis rates were comparable in both groups. At day 28, there were no statistically significant differences in clinical improvement or death between tocilizumab and standard therapy individuals in our cohort. Infections with bacteria or fungi were found in 13% of tocilizumab patients and 12% of standard therapy patients.
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 		32482597
(Eur J Intern Med)
PMID
32482597
Date of Publishing: 2020 Jun
Title Efficacy and safety of tocilizumab in severe COVID-19 patients: a single-centre retrospective cohort study
Author(s) nameCampochiaro C, Della-Torre E et al.
Journal Eur J Intern Med
Impact factor
3.05
Citation count: 208
Date of Entry 2022 Aug 26

Serious adverse events were reported in 8 (25%) of the tocilizumab group's patients and in 9 (27%) of the group receiving standard care. Both groups experienced a similar level of infection and pulmonary thrombosis. 13% of tocilizumab patients and 12% of patients receiving conventional care had bacterial or fungal infections, respectively.
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 		32482597
(Eur J Intern Med)
PMID
32482597
Date of Publishing: 2020 Jun
Title Efficacy and safety of tocilizumab in severe COVID-19 patients: a single-centre retrospective cohort study
Author(s) nameCampochiaro C, Della-Torre E et al.
Journal Eur J Intern Med
Impact factor
3.05
Citation count: 208
Date of Entry 2022 Aug 26

Two (13%) of 16 individuals getting conventional care and four (14%) of 29 patients receiving high-dose anakinra experienced bacteremia. Inflammatory relapses did not occur once anakinra was stopped.
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 		32501454
(Lancet Rheumatol)
PMID
32501454
Date of Publishing: 2020 Jun
Title Interleukin-1 blockade with high-dose anakinra in patients with COVID-19, acute respiratory distress syndrome, and hyperinflammation: a retrospective cohort study
Author(s) nameCavalli G, De Luca G et al.
Journal Lancet Rheumatol
Impact factor
- n/a -
Citation count: 473
Date of Entry 2022 Aug 26

Treatment with high-dose anakinra resulted in decreased levels of serum C-reactive protein and progressively better respiratory function in 21 (72%) of 29 patients at 21 days; five (17%) patients required mechanical ventilation, and three (10%) patients passed away. At 21 days, 8 (50%) of the 16 patients in the conventional treatment group had improved their respiratory function; 1 (6%) patient required mechanical ventilation, and 7 (44%) patients passed away. At 21 days, survival rates were 90% in the high-dose anakinra group and 56% in the group receiving standard care (p=0009). In the anakinra group, mechanical ventilation-free survival was 72% compared to 50% in the usual treatment group (p= 0.15).
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 		32501454
(Lancet Rheumatol)
PMID
32501454
Date of Publishing: 2020 Jun
Title Interleukin-1 blockade with high-dose anakinra in patients with COVID-19, acute respiratory distress syndrome, and hyperinflammation: a retrospective cohort study
Author(s) nameCavalli G, De Luca G et al.
Journal Lancet Rheumatol
Impact factor
- n/a -
Citation count: 473
Date of Entry 2022 Aug 26

In the convalescent plasma group, 98 of patients were discharged from the hospital, which is significantly greater than the 56 patients in the control group. When compared to the control group (12.88 days), the length of hospitalisation days in the convalescent plasma group was considerably less. Only 8 patients (7%) in the convalescent plasma group needed intubation, compared to 20% in the control group. This clinical trial demonstrates the efficacy of convalescent plasma therapy in COVID-19 patients and supports it as a treatment option for these individuals. Convalescent plasma therapy has several advantages, including clinical efficacy, fast availability, and potential cost effectiveness.
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 		32694043
(Transfus Apher Sci)
PMID
32694043
Date of Publishing: 2020 Oct
Title Clinical efficacy of convalescent plasma for treatment of COVID-19 infections: Results of a multicenter clinical study
Author(s) nameAbolghasemi H, Eshghi P et al.
Journal Transfus Apher Sci
Impact factor
1.36
Citation count: 80
Date of Entry 2022 Jun 20

In this case, successful therapeutic techniques show that early beginning of PE (Plasma Exchange) therapy followed by IVIG (Intravenous immunoglobulin) in critically sick COVID-19 patients may help to avoid disease progression and reduce the need for mechanical ventilation and extensive supportive care. Furthermore, it has the potential to improve these patients' dismal clinical results. Randomized controlled trials are urgently needed to confirm the efficacy of PE coupled with IVIG in COVID-19 patients who are critically unwell.
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 		32298745
(Int J Antimicrob Agents)
PMID
32298745
Date of Publishing: 2020 Aug
Title Successful treatment with plasma exchange followed by intravenous immunoglobulin in a critically ill patient with COVID-19
Author(s) nameShi H, Zhou C et al.
Journal Int J Antimicrob Agents
Impact factor
4.6
Citation count: 56
Date of Entry 2022 Jun 20

Mesenchymal cells were able to cure or improve the functional results of seven patients without causing any side effects. The function of the lungs and After MSC transplantation, the symptoms of the seven patients improved considerably in just two days.Following treatment, in 3-6 months, the number of peripheral lymphocytes increased, C-reactive protein dropped, and the overactive cytokine-secreting immune cells CXCR3+ CD4+ T cells, CXCR3+ CD8+ T cells, and CXCR3+ NK cells vanished. In addition, the population of CD14+ CD11c+ CD11bmid regulatory DC cells grew substantially.
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 		32257537
(Aging Dis)
PMID
32257537
Date of Publishing: 2020 Apr
Title Transplantation of ACE2 - Mesenchymal Stem Cells Improves the Outcome of Patients with COVID-19 Pneumonia
Author(s) nameLeng Z, Zhu R et al.
Journal Aging Dis
Impact factor
4.1
Citation count: 534
Date of Entry 2022 Jun 20

Prevalence of antibodies to Sars-Cov-2 Spike protein at baseline was higher in participants who were prescribed 800mg molnupiravir compared to participants prescribed placebo. Reduction in viral load and reduction in time to negative test was significantly reduced in participants prescribed 800mg molnupiravir compared to all other participants. Strong biological evidence of using molnupiravir as oral drug to reduce uninterrupted viral replication has been provided in this study.
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 		34941423
(Sci Transl Med)
PMID
34941423
Date of Publishing: 2021 Dec 23
Title A phase 2a clinical trial of molnupiravir in patients with COVID-19 shows accelerated SARS-CoV-2 RNA clearance and elimination of infectious virus
Author(s) nameFischer WA 2nd, Eron JJ Jr et al.
Journal Sci Transl Med
Impact factor
11.64
Citation count: 24
Date of Entry 2022 May 14

Participants who were administered molnupiravir had a better survival status at the interim analysis than participants who had been administered with the placebo. Lower percentage of participants from the molnupiravir group underwent incidence hospitalization or death by day 29, as compared to patients from the placebo group after randomized analysis.
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 		34914868
(N Engl J Med)
PMID
34914868
Date of Publishing: 2021 Dec 16
Title Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients
Author(s) nameJayk Bernal A, Gomes da Silva MM et al.
Journal N Engl J Med
Impact factor
37.91
Citation count: 101
Date of Entry 2022 May 14

In terms of clinical parameters, mortality, and median time to PCR negative, there was no statistically significant difference between ACEI/ARB users and non-users suffering from COVID-19. Non-users of ACEI/ARBs had a shorter median time from hospitalisation to ICU transfer.
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 		34618609
(Ann Saudi Med)
PMID
34618609
Date of Publishing: 2021 Sep-Oct
Title Patients with hypertension hospitalized with COVID-19 pneumonia using angiotensin converting enzyme inhibitors and angiotensin II receptor blockers or other antihypertensives: retrospective analysis of 435 patients
Author(s) name Baslilar S, Saylan B.
Journal Ann Saudi Med
Impact factor
N/A
Citation count: 1
Date of Entry 2022 May 14

Patients with COVID-19 who did not react to dexamethosone therapy did not demonstrate a clear benefit when given a combination of ciclosporin and favipiravir. 1. The rise in the patients' ferritin levels and white blood cell counts after the second dose of ciclosporin is not ascribed to ciclosporin.
2. Documented interaction between ciclosporin and favipiravir was not found.
3. This study did not evaluate ciclosporin's therapeutic effects as a single-agent therapy.
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 		34426105
(Int Immunopharmacol)
PMID
34426105
Date of Publishing: 2021 Aug 4
Title Combined Therapy of Ciclosporin Plus Favipiravir in the Management of Patients with Severe COVID-19, not Responding to Dexamethasone: A non-Controlled Prospective Trial
Author(s) nameBarati S, MohammadReza Hashemian S et al.
Journal Int Immunopharmacol
Impact factor
3.38
Citation count: 1
Date of Entry 2022 May 14

None of the participants who were administered molnupiravir faced any serious adverse effects. All of the participants who had been administered molnupiravir faced mild adverse effects.
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 		34450619
(J Antimicrob Chemother)
PMID
34450619
Date of Publishing: 2021 Aug 27
Title Optimal dose and safety of molnupiravir in patients with early SARS-CoV-2: a Phase I, open-label, dose-escalating, randomized controlled study
Author(s) nameKhoo SH, Fitzgerald R et al.
Journal J Antimicrob Chemother
Impact factor
4.94
Citation count: 16
Date of Entry 2022 May 14

Adalimumab in combination with remdesivir and dexamethosonedid not substantially vary from remdesivir and dexamethosonealone in terms of mortality rate (P-value = 1) and requirement of mechanical ventilation(P-value = 1) in severe COVID-19 cases. The length of hospital and ICU stays, as well as radiologic alterations, were unaffected (P-values = 1, 0.27, and 0.53 repsectively). 1. CRP levels were significantly lower in the intervention group, but this is not statistically significant because of the low sample size.
2. Ferritin levels were significantly higher in the intervention group, but this is not statistically significant because samples with documented ferritin levels were low.
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 		34426106
(Int Immunopharmacol)
PMID
34426106
Date of Publishing: 2021 Jul 7
Title Evaluation of adalimumab effects in managing severe cases of COVID-19: A randomized controlled trial
Author(s) nameFakharian A, Barati S et al.
Journal Int Immunopharmacol
Impact factor
3.38
Citation count: 5
Date of Entry 2022 May 14

Combination therapy with tocilizumab and dexamethasone is more effective than individual therapies of dexamethasone or tocilizumab. Combination therapy resulted in 9.36 QALYS saved. Cost effectiveness of using tocilizumab will increase if 400mg is used for second dose.
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 		33956936
(Clin Infect Dis)
PMID
33956936
Date of Publishing: 2021 May 6
Title Combination Therapy With Tocilizumab and Dexamethasone Cost-Effectively Reduces Coronavirus Disease 2019 Mortality
Author(s) name Sinha P, Linas BP.
Journal Clin Infect Dis
Impact factor
7.71
Citation count: 4
Date of Entry 2022 May 14