scholarly journals Safety and Efficacy of Hydroxychloroquine for Treatment of Non-Severe COVID-19 in Adults in Uganda: A Randomized Open Label Phase II Clinical Trial

2021 ◽  
Author(s):  
Pauline Byakika-Kibwika ◽  
Christine Sekaggya-Wiltshire ◽  
Jerome Roy Semakula ◽  
Jane Nakibuuka ◽  
Joseph Musaazi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Viral Load ◽  
Adverse Events ◽  
Phase Ii ◽  
Intervention Group ◽  
Viral Clearance ◽  
Phase Ii Clinical Trial ◽  
Control Group ◽  
Open Label ◽  
Open Label Phase

Abstract BackgroundSeveral repurposed drugs such as hydroxychloroquine (HCQ) have been investigated for treatment of COVID-19, but none was confirmed to be efficacious. While in vitro studies have demonstrated antiviral properties of HCQ, data from clinical trials were conflicting regarding its benefit for COVID-19 treatment. Drugs that limit viral replication may be beneficial in the earlier course of the disease thus slowing progression to severe and critical illness. DesignWe conducted a randomized open label Phase II clinical trial from October -December 2020.MethodsPatients diagnosed with COVID-19 using RT-PCR were included in the study if they were 18 years and above and had a diagnosis of COVID-19 made in the last 3 days. Patients were randomized in blocks, to receive either HCQ 400mg twice a day for the first day followed by 200mg twice daily for the next 4 days plus standard of care (SOC) treatment or SOC treatment alone. SARS COV-2 viral load using nasal/orapharyngeal swabs was performed at baseline, day 2, 4, 6, 8 and 10. The primary outcome was median time from randomization to SARS COV-2 viral clearance by day 6.ResultsOf the 105 participants enrolled, 55 were assigned to the intervention group (HCQ plus SOC) and 50 to the control group (SOC only). Baseline characteristics were similar across treatment arms. Viral clearance did not differ by treatment arm, 20 and 19 participants respectively had SARS COV-2 viral load clearance by day 6 with no significant difference, median (IQR) number of days to viral load clearance between the two groups was 4(3-4) vs 4(2-4): p=0.457. There were no significant differences in secondary outcomes (symptom resolution and adverse events) between the intervention group and the control group. There were no significant differences in specific adverse events such as elevated alkaline phosphatase, prolonged QTc interval on ECG, among patients in the intervention group as compared to the control group.ConclusionOur results show that HCQ 400mg twice a day for the first day followed by 200mg twice daily for the next 4 days was safe but not associated with reduction in viral clearance or symptom resolution. Trial registration: NCT04860284

scholarly journals Safety and efficacy of hydroxychloroquine for treatment of non-severe COVID-19 among adults in Uganda: a randomized open label phase II clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Pauline Byakika-Kibwika ◽  
Christine Sekaggya-Wiltshire ◽  
Jerome Roy Semakula ◽  
Jane Nakibuuka ◽  
Joseph Musaazi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Viral Load ◽  
Adverse Events ◽  
Phase Ii ◽  
Intervention Group ◽  
Viral Clearance ◽  
Control Group ◽  
Rt Pcr ◽  
Open Label ◽  
Open Label Phase

Abstract Background Several repurposed drugs such as hydroxychloroquine (HCQ) have been investigated for treatment of COVID-19, but none was confirmed to be efficacious. While in vitro studies have demonstrated antiviral properties of HCQ, data from clinical trials were conflicting regarding its benefit for COVID-19 treatment. Drugs that limit viral replication may be beneficial in the earlier course of the disease thus slowing progression to severe and critical illness. Design We conducted a randomized open label Phase II clinical trial from October–December 2020. Methods Patients diagnosed with COVID-19 using RT-PCR were included in the study if they were 18 years and above and had a diagnosis of COVID-19 made in the last 3 days. Patients were randomized in blocks, to receive either HCQ 400 mg twice a day for the first day followed by 200 mg twice daily for the next 4 days plus standard of care (SOC) treatment or SOC treatment alone. SARS COV-2 viral load (CT values) from RT-PCR testing of samples collected using nasal/orapharyngeal swabs was performed at baseline, day 2, 4, 6, 8 and 10. The primary outcome was median time from randomization to SARS COV-2 viral clearance by day 6. Results Of the 105 participants enrolled, 55 were assigned to the intervention group (HCQ plus SOC) and 50 to the control group (SOC only). Baseline characteristics were similar across treatment arms. Viral clearance did not differ by treatment arm, 20 and 19 participants respectively had SARS COV-2 viral load clearance by day 6 with no significant difference, median (IQR) number of days to viral load clearance between the two groups was 4(3–4) vs 4(2–4): p = 0.457. There were no significant differences in secondary outcomes (symptom resolution and adverse events) between the intervention group and the control group. There were no significant differences in specific adverse events such as elevated alkaline phosphatase, prolonged QTc interval on ECG, among patients in the intervention group as compared to the control group. Conclusion Our results show that HCQ 400 mg twice a day for the first day followed by 200 mg twice daily for the next 4 days was safe but not associated with reduction in viral clearance or symptom resolution among adults with COVID-19 in Uganda. Trial registration: NCT04860284.

Nitroglycerin (NTG) plus whole intracranial radiotherapy for brain metastases (BM) in non-small cell cancer patient (NSCLC): A randomized open label, phase II clinical trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9114-9114
Author(s):  
Oscar Gerardo Arrieta Rodriguez ◽  
Norma Hernández-Pedro ◽  
Federico Maldonado ◽  
Maritza Ramos ◽  
Masao Yamamoto-Ramos ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cell Lines ◽  
Phase Ii ◽  
Cell Cancer ◽  
Phase Ii Clinical Trial ◽  
Control Group ◽  
Open Label ◽  
Patient Subgroup ◽  
Open Label Phase ◽  
Nsclc Patients

9114 Background: Hypoxia has been associated with chemo-radioresistance secondary to Vascular Endothelial Growth Factor Receptor induced by Hypoxia Induced Factor (HIF). Nitroglycerin (NTG) can reduce HIF-1 in cell lines, and this may have anti-angiogenic, pro-apoptotic, and anti-efflux effects. Particularly, EGFR mutated (EGFRm) tumor cell lines have been shown to overexpress both VEGF and HIF. In this phase II study, we evaluated the effect of transdermal NTG on intracranial objective response rate (iORR), intracranial progression-free survival (ICPFS), and overall survival (OS) of NSCLC patients with BM. Methods: We performed an open-label, phase II clinical trial among ninety-six histologically confirmed NSCLC patients with BM. Patients were randomized 1:1 to receive NTG plus WBRT (30 Gy in 10 fractions) or WBRT alone. iORR and ICPFS were evaluated by MRI by two independent, blinded radiologists. Nitroglycerin was administered using a transdermal 36 mg patch, which released 10 mg in 24 hours with a rest interval of 12 hours from Monday-Friday throughout WBRT administration (10 days). Results: Fifty patients were allocated to the control group, while 46 were allocated to the experimental group (NTG); among these 26 (55.3%) had EGFRm in the control group and 21 (44.7%) had EGFRm in the NTG arm. In terms of the iORR, patients in the NTG group had a significantly higher response when compared to controls (56.6% vs. 43.5%; p = 0.024). Additionally, patients who received NTG in addition to WBRT had an independently prolonged ICPFS compared with those who received WBRT alone (27.7 vs. 9.6; HR: 0.470 [95%CI: 0.24-0.89]; p = 0.021). PFS was also positively impacted (HR: 0.519 [95%CI: 0.27-0.98]; p = 0.043). The benefit in terms of iORR and ICPFS (HR: 0.38 [95%CI: 0.16-0.91]; p = 0.030) was particularly important in the EGFRm patient subgroup. No differences were observed in OS. A significantly higher rate of vomiting presented in the NTG arm of the study ( p= 0.016). Conclusions: The concurrent administration of NTG and chemo-radiotherapy improves iORR and ICPFS among NSCLC patients with BM. The benefit is particularly significant in the EGFRm patient subgroup. Clinical trial information: NCT04338867.

REGOMA: A Randomized, Multicenter, Controlled Open-Label Phase II Clinical Trial of Regorafenib Compared to Lomustine in Relapsed Glioblastoma Patients

2018 ◽  
Author(s):  
Giuseppe Lombardi ◽  
Gian Luca De Salvo ◽  
Alba Ariela Brandes ◽  
Marica Eoli ◽  
Roberta Rudà ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Phase Ii Clinical Trial ◽  
Open Label ◽  
Open Label Phase

scholarly journals OS2.3 Updated results of REGOMA: A randomized, multicenter, controlled open-label phase II clinical trial evaluating regorafenib in relapsed glioblastoma patients

2018 ◽  
Vol 20 (suppl_3) ◽  
pp. iii219-iii219
Author(s):  
G Lombardi ◽  
G de Salvo ◽  
R Rudà ◽  
E Franceschi ◽  
M Eoli ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Phase Ii Clinical Trial ◽  
Open Label ◽  
Open Label Phase

Tu1448 Intragastric Injection of Botulinum Toxin a to Treat Gastric Cancer: An Open-Label Phase II Clinical Trial

2016 ◽  
Vol 150 (4) ◽  
pp. S1251-S1252
Author(s):  
Gøran Andersen ◽  
Chun-Mei Zhao ◽  
Xing Cai ◽  
Hanne-Line Rabben ◽  
James G. Fox ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Trial ◽  
Botulinum Toxin ◽  
Phase Ii ◽  
Botulinum Toxin A ◽  
Phase Ii Clinical Trial ◽  
Open Label ◽  
Toxin A ◽  
Open Label Phase
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